Systematic review of non-surgical therapies for osteoarthritis of the hand: an update.

PubMed

Lue, S; Koppikar, S; Shaikh, K; Mahendira, D; Towheed, T E

2017-09-01

To update our earlier systematic reviews which evaluated all published randomized controlled trials (RCTs) evaluating pharmacological and non-pharmacological therapies in patients with hand osteoarthritis (OA). Surgical therapies were not evaluated. RCTs published between March 2008 and December 2015 were added to the previous systematic reviews. A total of 95 RCTs evaluating various pharmacological and non-pharmacological therapies in hand OA were analyzed in this update. Generally, the methodological quality of these RCTs has improved since the last update, with more studies describing their methods for randomization, blinding, and allocation concealment. However, RCTs continue to be weakened by a lack of consistent case definition and a lack of standardized outcome assessments specific to hand OA. The number and location of evaluated hand joints continues to be underreported, and only 25% of RCTs adequately described the method used to ensure allocation concealment. These remain major weaknesses of published RCTs. A meta-analysis could not be performed because of marked study heterogeneity, insufficient statistical data available in the published RCTs, and a small number of identical comparators. Hand OA is a complex area in which to study the efficacy of therapies. There has been an improvement in the overall design and conduct of RCTs, however, additional large RCTs with a more robust methodological approach specific to hand OA are needed in order to make clinically relevant conclusions about the efficacy of the diverse treatment options available. Copyright © 2017 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Methodological reporting of randomized trials in five leading Chinese nursing journals.

PubMed

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955–2013

PubMed Central

Armijo-Olivo, Susan; Cummings, Greta G.; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

Objectives To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. Methods We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Results Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955–2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. Conclusions The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed. PMID:29272315

Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

PubMed

Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

2017-01-01

To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent methodology and detailed reporting of trials are still needed.

Quality of reporting of randomized clinical trials in implant dentistry. A systematic review on critical aspects in design, outcome assessment and clinical relevance.

PubMed

Cairo, Francesco; Sanz, Ignacio; Matesanz, Paula; Nieri, Michele; Pagliaro, Umberto

2012-02-01

The aim of this systematic review (SR) was to assess the quality of reporting randomized clinical trials (RCTs) in the field of implant dentistry, its evolution over time and the possible relations between quality items and reported outcomes. RCTs in implant dentistry were retrieved through electronic and hand searches. Risk of bias in individual studies was assessed focusing on study design, outcome assessment and clinical relevance. Associations between quality items and year of publication of RCTs or reporting of statistically significant outcomes were tested. Among the 495 originally screened manuscripts published from 1989 to April 2011, 276 RCTs were assessed in this SR; 59% of them were published between 2006 and 2011. RCTs were mainly parallel (65%), with a single centre (83%) and a superiority design (88%). Trials in implant dentistry showed several methodological flaws: only 37% showed a random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, only 12% performed a correct sample size calculation, the examiner was blind solely in 42% of studies where blinding was feasible. In addition, only 21% of RCTs declared operator experience and 31% reported patient-related outcomes. Many quality items improved over time. Allocation concealment at high risk of bias (p = 0.0125), no information on drop-out (p = 0.0318) and lack of CONSORT adherence (p = 0.0333) were associated with statistically significant reported outcomes. The overall quality of reporting of RCTs in implant dentistry is poor and only partially improved in the last years. Caution is suggested when interpreting these RCTs since risk of bias was associated with higher chance of reporting of statistically significant results. © 2012 John Wiley & Sons A/S.

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

PubMed

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions. Copyright© by the Chinese Pharmaceutical Association.

Worldwide trends in volume and quality of published protocols of randomized controlled trials

PubMed Central

Alldinger, Ingo; Cieslak, Kasia P.; Wennink, Roos; Clarke, Mike; Ali, Usama Ahmed; Besselink, Marc G. H.

2017-01-01

Introduction Publishing protocols of randomized controlled trials (RCT) facilitates a more detailed description of study rational, design, and related ethical and safety issues, which should promote transparency. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of published RCT protocols. Methods A systematic search was performed in PubMed and EMBASE, identifying RCT protocols published over a decade from 1 September 2001. Data were extracted on quality characteristics of RCT protocols. The primary outcome, methodological quality, was assessed by individual methodological characteristics (adequate generation of allocation, concealment of allocation and intention-to-treat analysis). A comparison was made by publication period (First, September 2001- December 2004; Second, January 2005-May 2008; Third, June 2008-September 2011), geographical region and medical specialty. Results The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common specialty topics. Whereas most published RCT protocols in the first period originated from North America (n = 30, 44%), in the second and third period this was Europe (respectively, n = 65, 47% and n = 190, 48%, p = 0.02). Quality of RCT protocols was higher in Europe and Australasia, compared to North America (OR = 0.63, CI = 0.40–0.99, p = 0.04). Adequate generation of allocation improved with time (44%, 58%, 67%, p = 0.001), as did concealment of allocation (38%, 53%, 55%, p = 0.03). Surgical protocols had the highest quality among the three specialty topics used in this study (OR = 1.94, CI = 1.09–3.45, p = 0.02). Conclusion Publishing RCT protocols has become popular, with a five-fold increase in the past decade. The quality of published RCT protocols also improved, although variation between geographical regions and across medical specialties was seen. This emphasizes the importance of international standards of comprehensive training in RCT methodology. PMID:28296925

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

PubMed Central

de SOUZA, Raphael Freitas; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; CHAVES, Carolina de Andrade Lima; NASSER, Mona; FEDOROWICZ, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-totreat analysis had been carried out. Results The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-totreat analysis or any similar procedure. Conclusions The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement. PMID:20485919

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO).

PubMed

de Souza, Raphael Freitas; Chaves, Carolina de Andrade Lima; Nasser, Mona; Fedorowicz, Zbys

2010-01-01

Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles.This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. CRITERIA TO ASSESS METHODOLOGICAL QUALITY INCLUDED: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e.g. the CONSORT statement.

Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference.

PubMed

Conradi, Una; Joffe, Ari R

2017-07-07

To determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A). We selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher's Exact Test. 62% (95% CI 52-71%) of studies described in A were subsequently P after a median 19 [IQR 9-33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001). Only 62% (95% CI 52-71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.

Methodological Reporting of Randomized Trials in Five Leading Chinese Nursing Journals

PubMed Central

Shi, Chunhu; Tian, Jinhui; Ren, Dan; Wei, Hongli; Zhang, Lihuan; Wang, Quan; Yang, Kehu

2014-01-01

Background Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. Methods In June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0. Results In total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34±0.97 (Mean ± SD). No RCT reported descriptions and changes in “trial design,” changes in “outcomes” and “implementation,” or descriptions of the similarity of interventions for “blinding.” Poor reporting was found in detailing the “settings of participants” (13.1%), “type of randomization sequence generation” (1.8%), calculation methods of “sample size” (0.4%), explanation of any interim analyses and stopping guidelines for “sample size” (0.3%), “allocation concealment mechanism” (0.3%), additional analyses in “statistical methods” (2.1%), and targeted subjects and methods of “blinding” (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of “participants,” “interventions,” and definitions of the “outcomes” and “statistical methods.” The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score. Conclusions The completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods. PMID:25415382

Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study.

PubMed

Dechartres, Agnes; Trinquart, Ludovic; Atal, Ignacio; Moher, David; Dickersin, Kay; Boutron, Isabelle; Perrodeau, Elodie; Altman, Douglas G; Ravaud, Philippe

2017-06-08

Objective  To examine how poor reporting and inadequate methods for key methodological features in randomised controlled trials (RCTs) have changed over the past three decades. Design  Mapping of trials included in Cochrane reviews. Data sources  Data from RCTs included in all Cochrane reviews published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items: sequence generation, allocation concealment, blinding, and incomplete outcome data. Data extraction  For each RCT, we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal. We matched journal names with Journal Citation Reports to get 2014 impact factors. Main outcomes measures  We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods, respectively. Results  We analysed 20 920 RCTs (from 2001 reviews) published in 3136 journals. The proportion of trials with unclear risk of bias was 48.7% for sequence generation and 57.5% for allocation concealment; the proportion of those with high risk of bias was 4.0% and 7.2%, respectively. For blinding and incomplete outcome data, 30.6% and 24.7% of trials were at unclear risk and 33.1% and 17.1% were at high risk, respectively. Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias. The proportion of trials at unclear risk of bias decreased over time, especially for sequence generation, which fell from 69.1% in 1986-1990 to 31.2% in 2011-14 and for allocation concealment (70.1% to 44.6%). After excluding trials at unclear risk of bias, use of inadequate methods also decreased over time: from 14.8% to 4.6% for sequence generation and from 32.7% to 11.6% for allocation concealment. Conclusions  Poor reporting and inadequate methods have decreased over time, especially for sequence generation and allocation concealment. But more could be done, especially in lower impact factor journals. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study

PubMed Central

2011-01-01

Background It was still unclear whether the methodological reporting quality of randomized controlled trials (RCTs) in major hepato-gastroenterology journals improved after the Consolidated Standards of Reporting Trials (CONSORT) Statement was revised in 2001. Methods RCTs in five major hepato-gastroenterology journals published in 1998 or 2008 were retrieved from MEDLINE using a high sensitivity search method and their reporting quality of methodological details were evaluated based on the CONSORT Statement and Cochrane Handbook for Systematic Reviews of interventions. Changes of the methodological reporting quality between 2008 and 1998 were calculated by risk ratios with 95% confidence intervals. Results A total of 107 RCTs published in 2008 and 99 RCTs published in 1998 were found. Compared to those in 1998, the proportion of RCTs that reported sequence generation (RR, 5.70; 95%CI 3.11-10.42), allocation concealment (RR, 4.08; 95%CI 2.25-7.39), sample size calculation (RR, 3.83; 95%CI 2.10-6.98), incomplete outecome data addressed (RR, 1.81; 95%CI, 1.03-3.17), intention-to-treat analyses (RR, 3.04; 95%CI 1.72-5.39) increased in 2008. Blinding and intent-to-treat analysis were reported better in multi-center trials than in single-center trials. The reporting of allocation concealment and blinding were better in industry-sponsored trials than in public-funded trials. Compared with historical studies, the methodological reporting quality improved with time. Conclusion Although the reporting of several important methodological aspects improved in 2008 compared with those published in 1998, which may indicate the researchers had increased awareness of and compliance with the revised CONSORT statement, some items were still reported badly. There is much room for future improvement. PMID:21801429

Quality of randomized controlled trials published in the International Urogynecology Journal 2007-2016.

PubMed

Kim, Kyu Shik; Chung, Jae Hoon; Jo, Jung Ki; Kim, Jae Heon; Kim, Seungjun; Cho, Jeoung Man; Cho, Hee Ju; Choi, Hong Yong; Lee, Seung Wook

2018-07-01

Randomized controlled trials (RCTs) provide the best quality clinical evidence. The aim of this study was to assess the quality of RCTs published by the International Urogynecology Journal (IUJ) in 2007-2016. RCTs in original articles were extracted from PubMed and IUJ homepage. Change in RCT quality over time was assessed with Jadad and van Tulder scales and Cochrane Collaboration's risk of bias tool (CCRBT). Jadad scores of 3-5 or van Tulder scores of >5 indicated high-quality RCTs. The effect on RCT quality of including funding source and institutional review board (IRB) approval statements and describing the intervention was assessed. In addition, changes in RCT topics over time were assessed. Annual RCT frequencies did not change significantly (6.7-15.7%): 36.1% and 25.7% described blinding and allocation concealment, respectively. Both tended to increase between 2013 and 2016, particularly 2013 and 2014. Funding statement inclusion (39.1% overall) and intervention description (78.2% overall) tended to increase steadily. IRB statement inclusion (60.4% overall) increased significantly (p < 0.01). Jadad scores and van Tulder rose significantly until 2014 (p < 0.01). Frequencies of high-quality RCTs tended to rise. CCRBT indicated that RCTs with a low risk of bias tended to increase until 2014. However, from 2015, Jadad scores, van Tulder, and CCRBT the low risk tended to decreased. RCTs with funding and IRB approval statements had higher Jadad and van Tulder scores than unfunded RCTs (p < 0.01 and p < 0.01, respectively). Intervention description did not associate with better quality. RCT quality improved over time, but a dip in quality was observed in 2015-2016 because of decreased blinding and allocation concealment.

Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review

PubMed Central

Krauth, David; Woodruff, Tracey J.

2013-01-01

Background: Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking. Objective: We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies. Method: We searched Medline (January 1966–November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument. Discussion: Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability. Conclusion: Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument. Citation: Krauth D, Woodruff TJ, Bero L. 2013. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect 121:985–992 (2013); http://dx.doi.org/10.1289/ehp.1206389 PMID:23771496

Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.

PubMed

Johnsen, Tone Langjordet; Eriksen, Hege Randi; Baste, Valborg; Indahl, Aage; Odeen, Magnus; Tveito, Torill Helene

2018-05-21

Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.

Test-treatment RCTs are susceptible to bias: a review of the methodological quality of randomized trials that evaluate diagnostic tests.

PubMed

Ferrante di Ruffano, Lavinia; Dinnes, Jacqueline; Sitch, Alice J; Hyde, Chris; Deeks, Jonathan J

2017-02-24

There is a growing recognition for the need to expand our evidence base for the clinical effectiveness of diagnostic tests. Many international bodies are calling for diagnostic randomized controlled trials to provide the most rigorous evidence of impact to patient health. Although these so-called test-treatment RCTs are very challenging to undertake due to their methodological complexity, they have not been subjected to a systematic appraisal of their methodological quality. The extent to which these trials may be producing biased results therefore remains unknown. We set out to address this issue by conducting a methodological review of published test-treatment trials to determine how often they implement adequate methods to limit bias and safeguard the validity of results. We ascertained all test-treatment RCTs published 2004-2007, indexed in CENTRAL, including RCTs which randomized patients to diagnostic tests and measured patient outcomes after treatment. Tests used for screening, monitoring or prognosis were excluded. We assessed adequacy of sequence generation, allocation concealment and intention-to-treat, appropriateness of primary analyses, blinding and reporting of power calculations, and extracted study characteristics including the primary outcome. One hundred three trials compared 105 control with 119 experimental interventions, and reported 150 primary outcomes. Randomization and allocation concealment were adequate in 57 and 37% of trials. Blinding was uncommon (patients 5%, clinicians 4%, outcome assessors 21%), as was an adequate intention-to-treat analysis (29%). Overall 101 of 103 trials (98%) were at risk of bias, as judged using standard Cochrane criteria. Test-treatment trials are particularly susceptible to attrition and inadequate primary analyses, lack of blinding and under-powering. These weaknesses pose much greater methodological and practical challenges to conducting reliable RCT evaluations of test-treatment strategies than standard treatment interventions. We suggest a cautious approach that first examines whether a test-treatment intervention can accommodate the methodological safeguards necessary to minimize bias, and highlight that test-treatment RCTs require different methods to ensure reliability than standard treatment trials. Please see the companion paper to this article: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0286-0 .

Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

PubMed

Sivaramakrishnan, Gowri; Sridharan, Kannan

2016-06-01

Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be laid down on the quality of trials being conducted in order to provide justice in the name of EBP. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of cefoxitin on preventing endometritis after uterine curettage for spontaneous incomplete abortion: a randomized controlled trial study.

PubMed

Titapant, Vitaya; Cherdchoogieat, Panida

2012-11-01

There are only few studies concerning the usage of antibiotics in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion and no conclusion can be demonstrated To investigate the effectiveness of prophylactic cefoxitin in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion. Eighty-four women with spontaneous first trimester incomplete abortion were randomly allocated into two groups using a computer-generated random number list and the allocation concealment was maintained using a sealed opaque envelope. The patients in the study group were given 1 g of cefoxitin while the patients in the control group were given 0.1 ml of vitamin B complex intravenously 20 minutes prior to curettage. Uterine curettage was performed after intravenous sedation and analgesic drugs were administered. The patients were evaluated on the first, third and seventh day after uterine curettage. Seventy-nine cases had completed the study protocol. There were no statistically significant differences in demographic data and details of uterine curettage between both groups. Two cases of endometritis were found in the control group but none in the study group. However the difference did not reach the statistical significance (p = 0.241). Prophylactic cefoxitin is not effective in preventing endometritis after uterine curettage for spontaneous first trimester incomplete abortion.

Efficacy of kinesio taping on isokinetic quadriceps torque in knee osteoarthritis: a double blinded randomized controlled study.

PubMed

Anandkumar, Sudarshan; Sudarshan, Shobhalakshmi; Nagpal, Pratima

2014-08-01

Double blind pre-test post-test control group design. To compare the isokinetic quadriceps torque, standardized stair-climbing task (SSCT) and pain during SSCT between subjects diagnosed with knee osteoarthritis pre and post kinesio tape (KT) application with and without tension. Strength of the quadriceps and torque producing capability is frequently found to be compromised in knee osteoarthritis. The efficacy of KT in improving isokinetic quadriceps torque in knee osteoarthritis is unknown, forming the basis for this study. Forty subjects were randomly allocated to either the experimental (therapeutic KT with tension) or control group (sham KT without tension) with the allocation being concealed. Pre and post test measurements of isokinetic quadriceps torque, SSCT and pain during SSCT were carried out by a blinded assessor. A large effect size with significant improvements in the peak quadriceps torque (concentric and eccentric at angular velocities of 90° per second and 120° per second), SSCT and pain were obtained in the experimental group when compared to the control group. Application of therapeutic KT is effective in improving isokinetic quadriceps torque, SSCT and reducing pain in knee osteoarthritis.

Dynamic detection-rate-based bit allocation with genuine interval concealment for binary biometric representation.

PubMed

Lim, Meng-Hui; Teoh, Andrew Beng Jin; Toh, Kar-Ann

2013-06-01

Biometric discretization is a key component in biometric cryptographic key generation. It converts an extracted biometric feature vector into a binary string via typical steps such as segmentation of each feature element into a number of labeled intervals, mapping of each interval-captured feature element onto a binary space, and concatenation of the resulted binary output of all feature elements into a binary string. Currently, the detection rate optimized bit allocation (DROBA) scheme is one of the most effective biometric discretization schemes in terms of its capability to assign binary bits dynamically to user-specific features with respect to their discriminability. However, we learn that DROBA suffers from potential discriminative feature misdetection and underdiscretization in its bit allocation process. This paper highlights such drawbacks and improves upon DROBA based on a novel two-stage algorithm: 1) a dynamic search method to efficiently recapture such misdetected features and to optimize the bit allocation of underdiscretized features and 2) a genuine interval concealment technique to alleviate crucial information leakage resulted from the dynamic search. Improvements in classification accuracy on two popular face data sets vindicate the feasibility of our approach compared with DROBA.

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

PubMed

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P

2010-09-30

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer.

PubMed

Rada, Gabriel; Schünemann, Holger J; Labedi, Nawman; El-Hachem, Pierre; Kairouz, Victor F; Akl, Elie A

2013-02-14

Randomized controlled trials (RCTs) that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer. We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL) up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH), low molecular weight heparin (LMWH), direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication. We included 67 RCTs with 24,071 participants. In twenty one trials (31%) DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%), 22 (33%), and 11 (16%) trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%), adequate allocation concealment (61%), participants' blinding (39%), data collectors' blinding (44%), providers' blinding (41%), outcome assessors' blinding (75%), data analysts' blinding (15%), intention to treat analysis (57%), no selective outcome reporting (12%), no stopping early for benefit (97%). The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time. Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological features. It is not clear whether this reflects a problem in the design, conduct or the reporting of these trials, or both. Future trials should avoid the shortcomings described in this article.

Comparison of in-vivo failure of single-thread and dual-thread temporary anchorage devices over 18 months: A split-mouth randomized controlled trial.

PubMed

Durrani, Owais Khalid; Shaheed, Sohrab; Khan, Arsalan; Bashir, Ulfat

2017-10-01

The purpose of this study was to compare the in-vivo failure rates of single-thread and dual-thread temporary anchorage device (TAD) designs over 18 months. Thirty patients with skeletal Class II Division 1 malocclusion requiring anchorage from TADs for retraction of maxillary incisors into the extracted premolar space were recruited in this parallel group, split-mouth, randomized controlled trial. A block randomization sequence was generated with Random Allocation Software (version 2.0; Isfahan, Iran) with the allocations concealed in sequentially numbered, opaque, sealed envelopes. A total of 60 TADs (diameter, 2 mm; length, 10 mm) were placed in the maxillary arches of these patients with random allocation of the 2 types to the left and the right sides in a 1:1 ratio. All TADs were placed between the roots of the second premolar and the first molar and were immediately loaded. Patients were followed for a minimum of 12 months and a maximum of 18 months for the failure of the TADs. Data were analyzed blindly on an intention-to-treat basis. Four TADs (13.3%) failed in the single-thread group, and 6 TADs (20%) failed in the dual-thread group. The McNemar test showed an insignificant difference (P = 0.72) between the 2 groups. An odds ratio of 1.6 (95% confidence interval, 0.39-6.97) showed no significant associations among the variables. Most TADs failed in the first month after insertion (50%). The failure rate of dual-thread TADs compared with single-thread TADs is statistically insignificant when placed in the maxilla for retraction of the anterior segment. Registration: The trial was not registered before commencement. The protocol was not published before the trial. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Deficiencies of effectiveness of intervention studies in veterinary medicine: a cross-sectional survey of ten leading veterinary and medical journals

PubMed Central

Meursinge Reynders, Reint

2016-01-01

The validity of studies that assess the effectiveness of an intervention (EoI) depends on variables such as the type of study design, the quality of their methodology, and the participants enrolled. Five leading veterinary journals and 5 leading human medical journals were hand-searched for EoI studies for the year 2013. We assessed (1) the prevalence of randomized controlled trials (RCTs) among EoI studies, (2) the type of participants enrolled, and (3) the methodological quality of the selected studies. Of 1707 eligible articles, 590 were EoI articles and 435 RCTs. Random allocation to the intervention was performed in 52% (114/219; 95%CI:45.2–58.8%) of veterinary EoI articles, against 87% (321/371; 82.5–89.7%) of human EoI articles (adjusted OR:9.2; 3.4–24.8). Veterinary RCTs were smaller (median: 26 animals versus 465 humans) and less likely to enroll real patients, compared with human RCTs (OR:331; 45–2441). Only 2% of the veterinary RCTs, versus 77% of the human RCTs, reported power calculations, primary outcomes, random sequence generation, allocation concealment and estimation methods. Currently, internal and external validity of veterinary EoI studies is limited compared to human medical ones. To address these issues, veterinary interventional research needs to improve its methodology, increase the number of published RCTs and enroll real clinical patients. PMID:26835187

Technology-assisted risk of bias assessment in systematic reviews: a prospective cross-sectional evaluation of the RobotReviewer machine learning tool.

PubMed

Gates, Allison; Vandermeer, Ben; Hartling, Lisa

2018-04-01

To evaluate the reliability of RobotReviewer's risk of bias judgments. In this prospective cross-sectional evaluation, we used RobotReviewer to assess risk of bias among 1,180 trials. We computed reliability with human reviewers using Cohen's kappa coefficient and calculated sensitivity and specificity. We investigated differences in reliability by risk of bias domain, topic, and outcome type using the chi-square test in meta-analysis. Reliability (95% CI) was moderate for random sequence generation (0.48 [0.43, 0.53]), allocation concealment (0.45 [0.40, 0.51]), and blinding of participants and personnel (0.42 [0.36, 0.47]); fair for overall risk of bias (0.34 [0.25, 0.44]); and slight for blinding of outcome assessors (0.10 [0.06, 0.14]), incomplete outcome data (0.14 [0.08, 0.19]), and selective reporting (0.02 [-0.02, 0.05]). Reliability for blinding of participants and personnel (P < 0.001), blinding of outcome assessors (P = 0.005), selective reporting (P < 0.001), and overall risk of bias (P < 0.001) differed by topic. Sensitivity and specificity (95% CI) ranged from 0.20 (0.18, 0.23) to 0.76 (0.72, 0.80) and from 0.61 (0.56, 0.65) to 0.95 (0.93, 0.96), respectively. Risk of bias appraisal is subjective. Compared with reliability between author groups, RobotReviewer's reliability with human reviewers was similar for most domains and better for allocation concealment, blinding of participants and personnel, and overall risk of bias. Copyright © 2018 Elsevier Inc. All rights reserved.

Small studies may overestimate the effect sizes in critical care meta-analyses: a meta-epidemiological study

PubMed Central

2013-01-01

Introduction Small-study effects refer to the fact that trials with limited sample sizes are more likely to report larger beneficial effects than large trials. However, this has never been investigated in critical care medicine. Thus, the present study aimed to examine the presence and extent of small-study effects in critical care medicine. Methods Critical care meta-analyses involving randomized controlled trials and reported mortality as an outcome measure were considered eligible for the study. Component trials were classified as large (≥100 patients per arm) and small (<100 patients per arm) according to their sample sizes. Ratio of odds ratio (ROR) was calculated for each meta-analysis and then RORs were combined using a meta-analytic approach. ROR<1 indicated larger beneficial effect in small trials. Small and large trials were compared in methodological qualities including sequence generating, blinding, allocation concealment, intention to treat and sample size calculation. Results A total of 27 critical care meta-analyses involving 317 trials were included. Of them, five meta-analyses showed statistically significant RORs <1, and other meta-analyses did not reach a statistical significance. Overall, the pooled ROR was 0.60 (95% CI: 0.53 to 0.68); the heterogeneity was moderate with an I2 of 50.3% (chi-squared = 52.30; P = 0.002). Large trials showed significantly better reporting quality than small trials in terms of sequence generating, allocation concealment, blinding, intention to treat, sample size calculation and incomplete follow-up data. Conclusions Small trials are more likely to report larger beneficial effects than large trials in critical care medicine, which could be partly explained by the lower methodological quality in small trials. Caution should be practiced in the interpretation of meta-analyses involving small trials. PMID:23302257

Restorations in abrasion/erosion cervical lesions: 8-year results of a triple blind randomized controlled trial.

PubMed

Dall'Orologio, Giovanni Dondi; Lorenzi, Roberta

2014-10-01

An equivalence randomized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer. 50 subjects, 21 males and 29 females aged between 21 and 65, were randomized to receive 150 restorations, 100 with the new restorative material, 50 with the composite as control, placed in non-carious cervical lesions with the same bonding system. The main outcome measure was the cause of failure at 8 years. Randomization was number table-generated, with allocation concealment by opaque sequentially numbered sealed and stapled envelopes. Subjects, examiner, and analyst were blinded to group assignment. Two interim analyses were performed. Data were analyzed by ANOVA and Cox test (P < 0.05). After 8 years, 40 subjects and 120 teeth were included in the analysis of the primary outcome. There were eight failures in the experimental group and four failures in the control group. The cumulative loss rate was 7% for both restorative materials, with the annual failure lower than 1%, without any statistically significant difference. There were two key elements of failure: the presence of sclerotic dentin and the relationship between lesion and gingival margin.

Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

PubMed Central

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P.

2010-01-01

Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials. PMID:20927344

The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

PubMed

Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

2017-05-03

The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

Digital Stratigraphy: Contextual Analysis of File System Traces in Forensic Science.

PubMed

Casey, Eoghan

2017-12-28

This work introduces novel methods for conducting forensic analysis of file allocation traces, collectively called digital stratigraphy. These in-depth forensic analysis methods can provide insight into the origin, composition, distribution, and time frame of strata within storage media. Using case examples and empirical studies, this paper illuminates the successes, challenges, and limitations of digital stratigraphy. This study also shows how understanding file allocation methods can provide insight into concealment activities and how real-world computer usage can complicate digital stratigraphy. Furthermore, this work explains how forensic analysts have misinterpreted traces of normal file system behavior as indications of concealment activities. This work raises awareness of the value of taking the overall context into account when analyzing file system traces. This work calls for further research in this area and for forensic tools to provide necessary information for such contextual analysis, such as highlighting mass deletion, mass copying, and potential backdating. © 2017 American Academy of Forensic Sciences.

Memory-Based Deception Detection: Extending the Cognitive Signature of Lying From Instructed to Self-Initiated Cheating.

PubMed

Geven, Linda M; Ben-Shakhar, Gershon; Kindt, Merel; Verschuere, Bruno

2018-06-15

From a cognitive perspective, lying can be regarded as a complex cognitive process requiring the interplay of several executive functions. Meta-analytic research on 114 studies encompassing 3,307 participants (Suchotzki, Verschuere, Van Bockstaele, Ben-Shakhar, & Crombez, ) suggests that computerized paradigms can reliably assess the cognitive burden of lying, with large reaction time differences between lying and truth telling. These studies, however, lack a key ingredient of real-life deception, namely self-initiated behavior. Research participants have typically been instructed to commit a mock crime and conceal critical information, whereas in real life, people freely choose whether or not to engage in antisocial behavior. In this study, participants (n = 433) engaged in a trivia quiz and were provided with a monetary incentive for high accuracy performance. Participants were randomly allocated to either a condition where they were instructed to cheat on the quiz (mimicking the typical laboratory set-up) or to a condition in which they were provided with the opportunity to cheat, yet without explicit instructions to do so. Assessments of their response times in a subsequent Concealed Information Test (CIT) revealed that both instructed cheaters (n = 107) and self-initiated cheaters (n = 142) showed the expected RT-slowing for concealed information. The data indicate that the cognitive signature of lying is not restricted to explicitly instructed cheating, but it can also be observed for self-initiated cheating. These findings are highly encouraging from an ecological validity perspective. Copyright © 2018 The Authors. Topics in Cognitive Science published by Wiley Periodicals, Inc. on behalf of Cognitive Science Society. Inc.

"Not clinically indicated": patients' interests or resource allocation?

PubMed Central

Hope, T; Sprigings, D; Crisp, R

1993-01-01

The decision that a particular intervention is not clinically indicated may conceal two quite different ethical assumptions. The first assumption is that the intervention is not of overall benefit to this patient. The second is that limited resources should not be used for this patient. These issues are discussed with reference to cardiac surgery in elderly patients with reference to the main theories of allocation: QALYs, needs theories, the sanctity of life theory, the lottery theory, and market forces. Images p380-a PMID:8461686

Randomized trial of constraint-induced movement therapy and bimanual training on activity outcomes for children with congenital hemiplegia.

PubMed

Sakzewski, Leanne; Ziviani, Jenny; Abbott, David F; Macdonell, Richard A L; Jackson, Graeme D; Boyd, Roslyn N

2011-04-01

To determine if constraint-induced movement therapy (CIMT) is more effective than bimanual training (BIM) in improving upper limb activity outcomes for children with congenital hemiplegia in a matched-pairs randomized trial. Sixty-three children (mean age 10.2, SD 2.7, range 5-16 y; 33 males, 30 females), 16 in Manual Ability Classification System level I, 46 level II, and 1 level III and 16 in Gross Motor Function Classification level I, 47 level II) were randomly allocated to either CIMT or BIM group day camps (60 hours over 10 days). The Melbourne Assessment of Unilateral Upper Limb Function assessed unimanual capacity of the impaired limb and Assisting Hand Assessment evaluated bimanual coordination at baseline, 3 and 26 weeks, scored by blinded raters. After concealed random allocation, there was no baseline difference between groups. CIMT had superior outcomes compared with BIM for unimanual capacity at 26 weeks (estimated mean difference [EMD] 4.4, 95% confidence interval [CI] 2.2-6.7; p < 0.001). There was no other significant difference between groups post-intervention. Both groups demonstrated significant improvements in bimanual performance at 3 weeks, with gains maintained by BIM at 26 weeks (EMD 2.3; 95% CI 0.6-4.0; p = 0.008). Interpretation  Overall, there were only small differences between the two training approaches. CIMT yielded greater changes in unimanual capacity of the impaired upper limb compared with BIM. Results generally reflect specificity of practice, with CIMT improving unimanual capacity and BIM improving bimanual performance. Considerable inter-individual variation in response to either intervention was evident. Future research should consider serial sequencing unimanual then BIM approaches to optimize upper limb outcomes for children with congenital hemiplegia. © The Authors. Journal compilation © Mac Keith Press 2011.

10 CFR 216.9 - Violations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Violations. 216.9 Section 216.9 Energy DEPARTMENT OF ENERGY OIL MATERIALS ALLOCATION AND PRIORITY PERFORMANCE UNDER CONTRACTS OR ORDERS TO MAXIMIZE DOMESTIC ENERGY SUPPLIES § 216.9 Violations. Any person who willfully furnishes false information or conceals any...

Trial of infographics in Northern Ireland (TINI): Preliminary evaluation and results of a randomized controlled trial comparing infographics with text.

PubMed

McCrorie, Alan David; Chen, Jingwen Jessica; Weller, Ross; McGlade, Kieran John; Donnelly, Conan

2018-06-01

Infographics represent a potential means of improving public knowledge about cancer. However, there is little experimental evidence of their efficacy. This preliminary study investigates whether infographics are superior to text for the communication of information about cancer risk in old age via a three armed randomized controlled trial. Trial involved allocation concealment and block randomization of 30 male participants aged over 50 to receive text information (control) or one of two infographics (interventions). Participants who viewed an infographic were more likely to know the correct association between cancer risk and old age compared with those viewing text information (risk ratio = 3.0, 95% confidence interval 0.82-10.90). Participants had limited understanding of the phrases "cancer incidence" and "cancer prevalence" but good understanding of the phrases "cancer risk factor" and "cancer stage." Possession of good numerical skills appears to be a key determinant of ability to extract meaning from statistical information provided; regardless of format. Initial results suggest icon array infographics may be more effective communication mediums than text but further study with more participants and an updated infographic is necessary to confirm this finding. ISRCTN33951209.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

PubMed

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

The Effects of Concealing Academic Achievement Information on Adolescents' Self-Concept

ERIC Educational Resources Information Center

Zhang, Baoshan; Wang, Mo; Li, Juan; Yu, Guoliang; Bi, Yan-Ling

2011-01-01

Using an experimental design, the effect of concealing academic achievement information on adolescents' self-concept was examined in the current study. Specifically, adolescents with low academic achievement and adolescents with average to high academic achievement (N = 129) were randomly assigned to different interview contexts wherein…

pRotective vEntilation with veno-venouS lung assisT in respiratory failure: A protocol for a multicentre randomised controlled trial of extracorporeal carbon dioxide removal in patients with acute hypoxaemic respiratory failure.

PubMed

McNamee, J J; Gillies, M A; Barrett, N A; Agus, A M; Beale, R; Bentley, A; Bodenham, A; Brett, S J; Brodie, D; Finney, S J; Gordon, A J; Griffiths, M; Harrison, D; Jackson, C; McDowell, C; McNally, C; Perkins, G D; Tunnicliffe, W; Vuylsteke, A; Walsh, T S; Wise, M P; Young, D; McAuley, D F

2017-05-01

One of the few interventions to demonstrate improved outcomes for acute hypoxaemic respiratory failure is reducing tidal volumes when using mechanical ventilation, often termed lung protective ventilation. Veno-venous extracorporeal carbon dioxide removal (vv-ECCO 2 R) can facilitate reducing tidal volumes. pRotective vEntilation with veno-venouS lung assisT (REST) is a randomised, allocation concealed, controlled, open, multicentre pragmatic trial to determine the clinical and cost-effectiveness of lower tidal volume mechanical ventilation facilitated by vv-ECCO 2 R in patients with acute hypoxaemic respiratory failure. Patients requiring intubation and mechanical ventilation for acute hypoxaemic respiratory failure will be randomly allocated to receive either vv-ECCO 2 R and lower tidal volume mechanical ventilation or standard care with stratification by recruitment centre. There is a need for a large randomised controlled trial to establish whether vv-ECCO 2 R in acute hypoxaemic respiratory failure can allow the use of a more protective lung ventilation strategy and is associated with improved patient outcomes.

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. Methods/design This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. Discussion This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Trial registration Current Controlled Trials ISRCTN40195031 PMID:23034084

Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.

PubMed

Overgaard, Hans J; Alexander, Neal; Mátiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Seidu, Razak; Stenström, Thor Axel

2012-10-03

Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools. This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation. This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings. Current Controlled Trials ISRCTN40195031.

Healing pressure ulcers with collagen or hydrocolloid: a randomized, controlled trial.

PubMed

Graumlich, James F; Blough, Linda S; McLaughlin, Richard G; Milbrandt, Joseph C; Calderon, Cesar L; Agha, Syed Abbas; Scheibel, L William

2003-02-01

To compare the effects of topical collagen and hydrocolloid on pressure ulcer healing. Randomized (allocation concealed), single-blind (outcome assessors), controlled trial with 8-week follow-up. Eleven nursing homes in central Illinois. Sixty-five patient-residents with Stage II or III pressure ulcers: median age 83.1, median Braden score 12, 63% female, 80% Stage II ulcers, and 20% Stage III ulcers. Exclusion criteria included cellulitis and osteomyelitis. Thirty-five patients were allocated to topical collagen daily, 30 to topical hydrocolloid twice weekly. The primary outcome was complete healing within 8 weeks. Secondary outcomes were time to heal, ulcer area healed per day, linear healing of wound edge, and cost of therapy. Analysis by intention to treat revealed similar complete ulcer healing within 8 weeks in collagen (51%) and hydrocolloid (50%) recipients (difference 1%, 95% confidence interval (CI) = 26-29%). Mean healing time was similar: collagen healed in 5 weeks (95% CI = 4-6), hydrocolloid healed in 6 weeks (95% CI = 5-7). Mean area healed per day was 6 mm(2)/d in both treatment groups. Mean linear healing of the wound edge was 3 mm in both groups. In multivariate analysis, baseline ulcer depth was the only independent predictor of complete ulcer healing within 8 weeks (odds ratio = 0.56, 95% CI = 0.38-0.81). Cost analysis favored hydrocolloid. There were no significant differences in healing outcome between collagen and hydrocolloid. Collagen was more expensive and offered no major benefits to patients otherwise eligible for hydrocolloid treatment.

A feasibility study of valerian extract for sleep disturbance in person with arthritis.

PubMed

Taibi, Diana M; Bourguignon, Cheryl; Gill Taylor, Ann

2009-04-01

To present a pilot study of valerian to explore issues of feasibility and efficacy in studies of sedative herbs for arthritis-related sleep disturbance. Fifteen persons with arthritis and mild sleep disturbance were randomized to receive 600 mg valerian (Valeriana officinalis, n = 7) or placebo (n = 8) for five nights. Protocol adherence (dosing and data collection) was high. Allocation concealment was successful using a novel approach for matching the placebo on the distinctive odor of valerian. Nonsignificant differences between the groups were found on all sleep outcomes, measured by daily diaries and wrist actigraphy. The study methods were feasible, except for recruitment issues (addressed in the discussion), and may guide the testing of other sedative herbs for persons with arthritis. Although efficacy outcomes were inconclusive due to the small sample size of this study, recent evidence from larger trials of valerian also does not support its efficacy.

Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial.

PubMed

Al-Sibaie, Salma; Hajeer, Mohammad Y

2014-06-01

No randomized controlled trial has tried to compare treatment outcomes between the sliding en-masse retraction of upper anterior teeth supported by mini-implants and the two-step sliding retraction technique employing conventional anchorage devices. To evaluate skeletal, dental, and soft tissue changes following anterior teeth retraction. Parallel-groups randomized controlled trial on patients with class II division 1 malocclusion treated at the University of Al-Baath Dental School in Hamah, Syria between July 2011 and May 2013. One hundred and thirty-three patients with an upper dentoalveolar protrusion were evaluated and 80 patients fulfilled the inclusion criteria. Randomization was performed using computer-generated tables; allocation was concealed using sequentially numbered opaque and sealed envelopes. Fifty-six participants were analysed (mean age 22.34 ± 4.56 years). They were randomly distributed into two groups with 28 patients in each group (1:1 allocation ratio). Following first premolar extraction, space closure was accomplished using either the en-masse technique with mini-implants or the two-step technique with transpalatal arches (TPAs). The antero-posterior displacements of upper incisal edges and upper first molars were measured on lateral cephalograms at three assessment times. Assessor blinding was employed. A bodily retraction (-4.42 mm; P < 0.001) with a slight intrusion (-1.53 mm; P < 0.001) of the upper anterior teeth was achieved in the mini-implants group, whereas upper anterior teeth retraction was achieved by controlled palatal tipping in the TPA group. When retracting anterior teeth in patients with moderate to severe protrusion, the en-masse retraction based on mini-implants anchorage gave superior results compared to the two-step retraction based on conventional anchorage in terms of speed, dental changes, anchorage loss, and aesthetic outcomes.

The effect of green tea extract supplementation on sputum smear conversion and weight changes in pulmonary TB patients: A randomized controlled trial

PubMed Central

Honarvar, Mohammad Reza; Eghtesadi, Shahryar; Gill, Pooria; Jazayeri, Shima; Vakili, Mohammad Ali; Shamsardekani, Mohammad Reza; Abbasi, Abdollah

2016-01-01

Background: Acceleration in sputum smear conversion helps faster improvement and decreased probability of the transfer of TB. In this study, we aimed to investigate the effect of green tea extract supplementation on sputum smear conversion and weight changes in smear positive pulmonary TB patients in Iran. Methods: In this double blind clinical study, TB patients were divided into intervention, (n=43) receiving 500 mg green tea extract (GTE), and control groups (n=40) receiving placebo for two months, using balanced randomization. Random allocation and allocation concealment were observed. Height and weight were measured at the beginning, and two and six months post-treatment. Evaluations were performed on three slides, using the ZiehlNeelsen method. Independent and paired t test, McNemar’s, Wilcoxon, Kaplan-Meier, Cox regression model and Log-Rank test were utilized. Statistical significance was set at p<0.05. This trial was registered under IRCT201212232602N11. Results: The interventional changes and the interactive effect of intervention on weight were not significant (p>0.05). In terms of shortening the duration of conversion, the case to control proportion showed a significant difference (p=0.032). Based on the Cox regression model, the hazard ratio of the relative risk of delay in sputum smear conversion was 3.7 (p=0.002) in the higher microbial load group compared to the placebo group and 0.54 (95% CI: 0.31-0.94) in the intervention compared to the placebo group. Conclusion: GTE decreases the risk of delay in sputum smear conversion, but has no effect on weight gain. Moreover, it may be used as an adjuvant therapy for faster rehabilitation for pulmonary TB patients. PMID:27493925

Efficacy of virtual reality exposure therapy for treatment of dental phobia: a randomized control trial.

PubMed

Raghav, Kumar; Van Wijk, A J; Abdullah, Fawzia; Islam, Md Nurul; Bernatchez, Marc; De Jongh, Ad

2016-02-27

Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET. This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis. This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia. ISRCTN25824611 , Date of registration: 26 October 2015.

Quality of reporting of modern randomized controlled trials in medical oncology: a systematic review.

PubMed

Péron, Julien; Pond, Gregory R; Gan, Hui K; Chen, Eric X; Almufti, Roula; Maillet, Denis; You, Benoit

2012-07-03

The Consolidated Standards of Reporting Trials (CONSORT) guidelines were developed in the mid-1990s for the explicit purpose of improving clinical trial reporting. However, there is little information regarding the adherence to CONSORT guidelines of recent publications of randomized controlled trials (RCTs) in oncology. All phase III RCTs published between 2005 and 2009 were reviewed using an 18-point overall quality score for reporting based on the 2001 CONSORT statement. Multivariable linear regression was used to identify features associated with improved reporting quality. To provide baseline data for future evaluations of reporting quality, RCTs were also assessed according to the 2010 revised CONSORT statement. All statistical tests were two-sided. A total of 357 RCTs were reviewed. The mean 2001 overall quality score was 13.4 on a scale of 0-18, whereas the mean 2010 overall quality score was 19.3 on a scale of 0-27. The overall RCT reporting quality score improved by 0.21 points per year from 2005 to 2009. Poorly reported items included method used to generate the random allocation (adequately reported in 29% of trials), whether and how blinding was applied (41%), method of allocation concealment (51%), and participant flow (59%). High impact factor (IF, P = .003), recent publication date (P = .008), and geographic origin of RCTs (P = .003) were independent factors statistically significantly associated with higher reporting quality in a multivariable regression model. Sample size, tumor type, and positivity of trial results were not associated with higher reporting quality, whereas funding source and treatment type had a borderline statistically significant impact. The results show that numerous items remained unreported for many trials. Thus, given the potential impact of poorly reported trials, oncology journals should require even stricter adherence to the CONSORT guidelines.

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

PubMed

Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

2018-06-01

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

University Presidents' Perceptions and Practice Regarding the Carrying of Concealed Handguns on College Campuses

ERIC Educational Resources Information Center

Price, James H.; Thompson, Amy; Khubchandani, Jagdish; Dake, Joseph; Payton, Erica; Teeple, Karen

2014-01-01

Objective: To assess the perceptions and practices of a national sample of college and university presidents regarding their support for concealed handguns being carried on college campuses. Participants: The sample for this study consisted of a national random sample of 900 college or university presidents. Methods: In the spring of 2013, a…

Mind-Body Interventions for Irritable Bowel Syndrome Patients in the Chinese Population: a Systematic Review and Meta-Analysis.

PubMed

Wang, Weidong; Wang, Fang; Fan, Feng; Sedas, Ana Cristina; Wang, Jian

2017-04-01

The aim of this study is to identify and assess evidence related to the efficacy of mind-body interventions on irritable bowel syndrome (IBS) in the Chinese population. Drawn from Chinese databases, nine RCTs and three Q-E studies were included in the systematic review. The methodological quality of RCTs was evaluated based on the following criteria: adequate sequence generation, allocation concealment, blinding, completeness of outcome data, selective reporting, and other potential biases. For continuous variables, the effect size (ES) was determined by calculating the standardized mean difference between groups. For dichotomous variables, the ES was determined by calculating the risk ratio (RR) between groups. Given the heterogeneity between the trials and the small number of studies included, both random effects and fixed effects models were used. The inverse variance method was used for pooling. Statistical analyses were performed using Review Manager version 5.0. The total number of papers identified was 710: 462 from English language databases and 248 from Chinese language databases. Twelve studies met our eligibility criteria. Among the studies selected, three were Q-E studies the rest RCTs. Two studies described the randomization process. None of the studies reported allocation concealment nor blinding. Seven studies reported no dropouts. One of the studies mentioned the total amount of dropouts; though the reason for dropping out was not referenced. The other four studies did not clearly report dropouts. With the exception of three studies, there was inadequate information to determine biased reporting for the majority; the level of risk for bias in these studies is unclear. Finally, six meta-analyses were performed. One was conducted with four randomized controlled trials (RCTs) that used cure rate as outcome measures to evaluate gastrointestinal (GI) symptoms, which suggested that mind-body interventions were effective in improving GI symptoms (random effects model: RR = 1.08; 95 % CI 1.01 to 1.17; fixed effects model: RR = 1.07; 95 % CI 1.01 to 1.12). The remaining five were conducted in three RCTs, which suggested that mind-body interventions were effective in improving several aspects of quality of life, including interference with activity (random effects and fixed effects models: SMD = 0.64; 95 % CI 0.41 to 0.86), body image (random effects model: SMD = 0.36; 95 % CI 0.06 to 0.67; fixed effects model: SMD = 0.33; 95 % CI 0.11 to 0.55), health worry (random effects and fixed effects models: SMD = 0.67; 95 % CI 0.44 to 0.90), food avoidance (random effects and fixed effects models: SMD = 0.45; 95 % CI 0.23 to 0.68), and social reaction (random effects model: SMD = 0.79; 95 % CI 0.47 to 1.12; fixed effects model: SMD = 0.78; 95 % CI 0.55 to 1.01), as measured by Irritable Bowel Syndrome Quality of Life Questionnaire ( IBS-QOL). Mind-body interventions may have the potential to improve GI symptoms in Chinese patients with IBS. The improvement of GI symptoms was also accompanied with the improvement of various outcomes, including depression, anxiety, and quality of life, just to mention a few. However, the published studies generally had significant methodological limitations. Future clinical trials with rigorous research design are needed in this field. More studies focusing on the mind-body interventions originated in China, such as tai chi and qi gong should be encouraged.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis.

PubMed

Bala, Malgorzata M; Akl, Elie A; Sun, Xin; Bassler, Dirk; Mertz, Dominik; Mejza, Filip; Vandvik, Per Olav; Malaga, German; Johnston, Bradley C; Dahm, Philipp; Alonso-Coello, Pablo; Diaz-Granados, Natalia; Srinathan, Sadeesh K; Hassouneh, Basil; Briel, Matthias; Busse, Jason W; You, John J; Walter, Stephen D; Altman, Douglas G; Guyatt, Gordon H

2013-03-01

To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals. We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals. Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P < 0.05 for all differences. RCTs published in higher impact journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias. Copyright © 2013 Elsevier Inc. All rights reserved.

An Assessment of the Risk of Bias in Randomized Controlled Trial Reports Published in Prosthodontic and Implant Dentistry Journals.

PubMed

Papageorgiou, Spyridon N; Kloukos, Dimitrios; Petridis, Haralampos; Pandis, Nikolaos

2015-01-01

The objective of this study was to assess the risk of bias of randomized controlled trials (RCTs) published in prosthodontic and implant dentistry journals. The last 30 issues of 9 journals in the field of prosthodontic and implant dentistry (Clinical Implant Dentistry and Related Research, Clinical Oral Implants Research, Implant Dentistry, International Journal of Oral & Maxillofacial Implants, International Journal of Periodontics and Restorative Dentistry, International Journal of Prosthodontics, Journal of Dentistry, Journal of Oral Rehabilitation, and Journal of Prosthetic Dentistry) were hand-searched for RCTs. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool and analyzed descriptively. From the 3,667 articles screened, a total of 147 RCTs were identified and included. The number of published RCTs increased with time. The overall distribution of a high risk of bias assessment varied across the domains of the Cochrane risk of bias tool: 8% for random sequence generation, 18% for allocation concealment, 41% for masking, 47% for blinding of outcome assessment, 7% for incomplete outcome data, 12% for selective reporting, and 41% for other biases. The distribution of high risk of bias for RCTs published in the selected prosthodontic and implant dentistry journals varied among journals and ranged from 8% to 47%, which can be considered as substantial.

[Report quality of randomized controlled trials of moxibustion for knee osteoarthritis based on CONSORT and STRICTOM].

PubMed

Xiong, Jun; Zhu, Daocheng; Chen, Rixin; Ye, Wenguo

2015-08-01

The report quality of randomized controlled trials (RCTs) of moxibustion for knee osteoarthritis (KOA) in China was evaluated by Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Moxibustion (STRICTOM). Computer and manual retrieval was used. Four databases of China National Knowledge Infrastructure (CNKD, China Biomedicine (CBM), VIP and WNFANG were searched in combination with manual retrieval for relevant journals to screen the literature that: met the inclusive criteria, and CONSORT and STRICTOM were used to assess the report quality. A total of 52 RCTs were included. It was found that unclear description of random methods, low use of blind methods, no allocation concealment, no sample size calculation, no intention-to-treat analysis,inadequate report of moxibustion details and no mention of practitioners background existed in the majority of the RCTs. Although the quality of RCTs of moxibustion for KOA was generally low, reducing the reliability and homogeneous comparability of the reports ,the quality of heat-sensitive moxibustion RCTs was high. It was believed that in order to improve the reliability and quality of RCTs of moxibustion, CONSORT and STRICTOM should be introduced into the RCT design of moxibustion and be strictly performed.

A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Permanent joint damage is a major consequence of rheumatoid arthritis (RA), the most common and destructive form of inflammatory arthritis. In aggressive disease, joint damage can occur within 6 months from symptom onset. Early, intensive treatment with conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) can delay the onset and progression of joint damage. The primary objective of the study is to investigate the value of magnetic resonance imaging (MRI) or radiography (X-ray) over standard of care as tools to guide DMARD treatment decision-making by rheumatologists for the care of RA. Methods A double-blind, randomized controlled trial has been designed. Rheumatoid and undifferentiated inflammatory arthritis patients will undergo an MRI and X-ray assessment every 6 months. Baseline adaptive randomization will be used to allocate participants to MRI, X-ray, or sham-intervention groups on a background of standard of care. Prognostic markers, treating physician, and baseline DMARD therapy will be used as intervention allocation parameters. The outcome measures in rheumatology RA MRI score and the van der Heijde-modified Sharp score will be used to evaluate the MRI and X-ray images, respectively. Radiologists will score anonymized images for all patients regardless of intervention allocation. Disease progression will be determined based on the study-specific, inter-rater smallest detectable difference. Allocation-dependent, intervention-concealed reports of positive or negative disease progression will be reported to the treating rheumatologist. Negative reports will be delivered for the sham-intervention group. Study-based radiology clinical reports will be provided to the treating rheumatologists for extra-study X-ray requisitions to limit patient radiation exposure as part of diagnostic imaging standard of care. DMARD treatment dose escalation and therapy changes will be measured to evaluate the primary objective. A sample size of 186 (62 per group) patients will be required to determine a 36% difference in pharmacological treatment escalation between the three groups with intermediate dispersion of data with 90% power at a 5% level of significance. Discussion This study will determine if monitoring RA and undifferentiated inflammatory arthritis patients using MRI and X-ray every 6 months over 2 years provides incremental evidence over standard of care to influence pharmacotherapeutic decision-making and ultimately hinder disease progression. Trial registration This trial has been registered at ClinicalTrials.gov: NCT00808496 (registered on 12 December 2008). PMID:24997587

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

Effect of parent-delivered action observation therapy on upper limb function in unilateral cerebral palsy: a randomized controlled trial.

PubMed

Kirkpatrick, Emma; Pearse, Janice; James, Peter; Basu, Anna

2016-10-01

To determine whether home-based, parent-delivered therapy comprising action observation (AO) and repeated practice (RP) improves upper limb function more than RP alone in children with unilateral cerebral palsy (UCP). single-blinded parallel-group randomized controlled trial with 1:1 allocation comparing AO+RP (intervention) with RP alone (control). computer-generated, with allocation concealment by opaque sequentially-numbered envelopes. northern England, August 2011 to September 2013. 70 children with UCP; mean age 5.6 years (SD 2.1), 31 female. home-based activities were provided, tailored to interests and abilities. 15 minutes/day, 5 days/week for 3 months. Assisting Hand Assessment (AHA; primary outcome measure), Melbourne Assessment 2 (MA2), and ABILHAND-Kids at baseline, 3 months, and 6 months. Outcome data was available at 3 months for 28 children in the AO+RP group and 31 controls, and at 6 months for 26 and 28 children respectively. There were no between-group differences in AHA, MA2, or ABILHAND-Kids at 3 or 6 months versus baseline (all p>0.05). Combined-group improvements (p<0.001), observed in AHA and MA2 at 3 months, were maintained at 6 months. ABILHAND-Kids also showed improvement at 3 months (p=0.003), maintained at 6 months. Parent-delivered RP (with or without AO) improves upper limb function and could supplement therapist input. © 2016 The Authors. Developmental Medicine & Child Neurology published by John Wiley & Sons Ltd on behalf of Mac Keith Press.

Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database.

PubMed

Ferreira, Christiane Alves; Loureiro, Carlos Alfredo Salles; Saconato, Humberto; Atallah, Alvaro Nagib

2011-03-01

Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

Sexual intercourse for cervical ripening and induction of labour.

PubMed

Kavanagh, J; Kelly, A J; Thomas, J

2001-01-01

The role of prostaglandins for cervical ripening and induction of labour has been examined extensively. Human semen is the biological source that is presumed to contain the highest prostaglandin concentration. The role of sexual intercourse in the initiation of labour is uncertain. The action of sexual intercourse in stimulating labour is unclear, it may in part be due to the physical stimulation of the lower uterine segment, or endogenous release of oxytocin as a result of orgasm or from the direct action of prostaglandins in semen. Furthermore nipple stimulation may be part of the process of initiation. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. To determine the effects of sexual intercourse for third trimester cervical ripening or induction of labour in comparison with other methods of induction. The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and bibliographies of relevant papers. Last searched: November 2000. (1) clinical trials comparing sexual intercourse for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusion. A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involves a two-stage method of data extraction. There was one included study of 28 women which reported very limited data, from which no meaningful conclusions can be drawn. The role of sexual intercourse as a method of induction of labour is uncertain. Any future trials investigating sexual intercourse as a method of induction need to be of sufficient power to detect clinically relevant differences in standard outcomes. However, it may prove difficult to standardise sexual intercourse as an intervention to allow meaningful comparisons with other methods of induction of labour.

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols

PubMed Central

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P.; Kumar, Ambuj

2011-01-01

Objectives To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Study design Systematic review Setting Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Results 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. Conclusion The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. PMID:22424985

Quality of reporting in oncology studies: A systematic analysis of literature reviews and prospects.

PubMed

Rivoirard, Romain; Bourmaud, Aurélie; Oriol, Mathieu; Tinquaut, Fabien; Méry, Benoîte; Langrand-Escure, Julien; Vallard, Alexis; Fournel, Pierre; Magné, Nicolas; Chauvin, Franck

2017-04-01

The present review gives an overview of systematic reviews published in peer reviewed Journals analysing quality of reporting in oncology studies. PUBMED and Cochrane library were searched to identify systematic reviews assessing quality of reporting for randomized controlled trials (RCTs) and observational studies (OBS). Recommendations and primary endpoints used to assess the quality of reporting were described. Intrinsic quality of reporting was analyzed using an Overall Quality Score for literature Reviews (OQSR). Main evaluation themes were overall quality of reporting (20/58) and reporting of Health-Related Quality Of Life (HRQOL) in RCTs (7/58). Reporting recommendations used were not detailed in 56.9% of reviews. Insufficient reporting for the methodological description (randomization, blinding details, and allocation concealment) and the rationale for using specific measure of HRQOL were highlighted. OQSR was significantly higher for reviews published between 2010 and 2014 (after the PRISMA Publication), as compared to those published between 1996-2009 (median OQSR 10 (10-11) versus median OQSR 9 (6-10) respectively, p=0.0053). Intrinsic quality of reporting is satisfactory and has been improved in the last years. Copyright © 2017 Elsevier B.V. All rights reserved.

Preventing Shoulder-Surfing Attack with the Concept of Concealing the Password Objects' Information

PubMed Central

Ho, Peng Foong; Kam, Yvonne Hwei-Syn; Wee, Mee Chin

2014-01-01

Traditionally, picture-based password systems employ password objects (pictures/icons/symbols) as input during an authentication session, thus making them vulnerable to “shoulder-surfing” attack because the visual interface by function is easily observed by others. Recent software-based approaches attempt to minimize this threat by requiring users to enter their passwords indirectly by performing certain mental tasks to derive the indirect password, thus concealing the user's actual password. However, weaknesses in the positioning of distracter and password objects introduce usability and security issues. In this paper, a new method, which conceals information about the password objects as much as possible, is proposed. Besides concealing the password objects and the number of password objects, the proposed method allows both password and distracter objects to be used as the challenge set's input. The correctly entered password appears to be random and can only be derived with the knowledge of the full set of password objects. Therefore, it would be difficult for a shoulder-surfing adversary to identify the user's actual password. Simulation results indicate that the correct input object and its location are random for each challenge set, thus preventing frequency of occurrence analysis attack. User study results show that the proposed method is able to prevent shoulder-surfing attack. PMID:24991649

Clinical trials in dentistry in India: Analysis from trial registry.

PubMed

Gowri, S; Kannan, Sridharan

2017-01-01

Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy participants. From 2011, some of the postgraduate thesis trials had also been registered (2011-8; 2012-8; 2013-13; 2014-6). Inadequacy in reporting the method of randomization and allocation concealment was observed in 37/67 (55.2%) and 31/67 (46.2%) clinical trials respectively. A considerable number of postgraduate theses was also registered with CTRI in dentistry and majority of the clinical trials despite being completed are not yet published. The number of clinical trials in dentistry are low in India, and more focus should be placed by dental investigators regarding the reporting standards. Furthermore, researchers and trial sponsors should aim at publication of the research findings so that it is made publically available for use. A clear-cut need exists for an increase in both the quantity and quality of clinical trials in dentistry.

Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial.

PubMed

Alfawal, Alaa M H; Hajeer, Mohammad Y; Ajaj, Mowaffak A; Hamadah, Omar; Brad, Bassel

2018-02-17

To evaluate the effectiveness of two minimally invasive surgical procedures in the acceleration of canine retraction: piezocision and laser-assisted flapless corticotomy (LAFC). Trial design: A single-centre randomized controlled trial with a compound design (two-arm parallel-group design and a split-mouth design for each arm). 36 Class II division I patients (12 males, 24 females; age range: 15 to 27 years) requiring first upper premolars extraction followed by canine retraction. piezocision group (PG; n = 18) and laser-assisted flapless corticotomy group (LG; n = 18). A split-mouth design was applied for each group where the flapless surgical intervention was randomly allocated to one side and the other side served as a control side. the rate of canine retraction (primary outcome), anchorage loss and canine rotation, which were assessed at 1, 2, 3 and 4 months following the onset of canine retraction. Also the duration of canine retraction was recorded. Random sequence: Computer-generated random numbers. Allocation concealment: sequentially numbered, opaque, sealed envelopes. Blinding: Single blinded (outcomes' assessor). Seventeen patients in each group were enrolled in the statistical analysis. The rate of canine retraction was significantly greater in the experimental side than in the control side in both groups by two-fold in the first month and 1.5-fold in the second month (p < 0.001). Also the overall canine retraction duration was significantly reduced in the experimental side as compared with control side in both groups about 25% (p ≤ 0.001). There were no significant differences between the experimental and the control sides regarding loss of anchorage and upper canine rotation in both groups (p > 0.05). There were no significant differences between the two flapless techniques regarding the studied variables during all evaluation times (p > 0.05). Piezocision and laser-assisted flapless corticotomy appeared to be effective treatment methods for accelerating canine retraction without any significant untoward effect on anchorage or canine rotation during rapid retraction. ClinicalTrials.gov (Identifier: NCT02606331 ).

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.

PubMed

Bradt, Joke

2012-01-01

Evidence from randomized controlled trials (RCTs) plays a powerful role in today's healthcare industry. At the same time, it is important that multiple types of evidence contribute to music therapy's knowledge base and that the dialogue of clinical effectiveness in music therapy is not dominated by the biomedical hierarchical model of evidence-based practice. Whether or not one agrees with the hierarchical model of evidence in the current healthcare climate, RCTs can contribute important knowledge to our field. Therefore, it is important that music therapists are prepared to design trials that meet current methodological standards and, equally important, are able to respond appropriately to those design aspects that may not be feasible in music therapy research. To provide practical guidelines to music therapy researchers for the design and implementation of RCTs as well as to enable music therapists to be well-informed consumers of RCT evidence. This article reviews key design aspects of RCTs and discusses how to best implement these standards in music therapy trials. A systematic presentation of basic randomization methods, allocation concealment strategies, issues related to blinding in music therapy trials and strategies for implementation, the use of treatment manuals, types of control groups, outcome selection, and sample size computation is provided. Despite the challenges of meeting all key design demands typical of an RCT, it is possible to design rigorous music therapy RCTs that accurately estimate music therapy treatment benefits.

Parent-only interventions in the treatment of childhood obesity: a systematic review of randomized controlled trials.

PubMed

Ewald, H; Kirby, J; Rees, K; Robertson, W

2014-09-01

An effective and cost-effective treatment is required for the treatment of childhood obesity. Comparing parent-only interventions with interventions including the child may help determine this. A systematic review of published and ongoing studies until 2013, using electronic database and manual searches. randomized controlled trials, overweight/obese children aged 5-12 years, parent-only intervention compared with an intervention that included the child, 6 months or more follow-up. Outcomes included measures of overweight. Ten papers from 6 completed studies, and 2 protocols for ongoing studies, were identified. Parent-only groups are either more effective than or similarly effective as child-only or parent-child interventions, in the change in degree of overweight. Most studies were at unclear risk of bias for randomization, allocation concealment and blinding of outcome assessors. Two trials were at high risk of bias for incomplete outcome data. Four studies showed higher dropout from parent-only interventions. One study examined programme costs and found parent-only interventions to be cheaper. Parent-only interventions appear to be as effective as parent-child interventions in the treatment of childhood overweight/obesity, and may be less expensive. Reasons for higher attrition rates in parent-only interventions need further investigation. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Experimental design and reporting standards for improving the internal validity of pre-clinical studies in the field of pain: Consensus of the IMI-Europain consortium.

PubMed

Knopp, K L; Stenfors, C; Baastrup, C; Bannon, A W; Calvo, M; Caspani, O; Currie, G; Finnerup, N B; Huang, W; Kennedy, J D; Lefevre, I; Machin, I; Macleod, M; Rees, H; Rice, A S C; Rutten, K; Segerdahl, M; Serra, J; Wodarski, R; Berge, O-G; Treedef, R-D

2017-12-29

Background and aims Pain is a subjective experience, and as such, pre-clinical models of human pain are highly simplified representations of clinical features. These models are nevertheless critical for the delivery of novel analgesics for human pain, providing pharmacodynamic measurements of activity and, where possible, on-target confirmation of that activity. It has, however, been suggested that at least 50% of all pre-clinical data, independent of discipline, cannot be replicated. Additionally, the paucity of "negative" data in the public domain indicates a publication bias, and significantly impacts the interpretation of failed attempts to replicate published findings. Evidence suggests that systematic biases in experimental design and conduct and insufficiencies in reporting play significant roles in poor reproducibility across pre-clinical studies. It then follows that recommendations on how to improve these factors are warranted. Methods Members of Europain, a pain research consortium funded by the European Innovative Medicines Initiative (IMI), developed internal recommendations on how to improve the reliability of pre-clinical studies between laboratories. This guidance is focused on two aspects: experimental design and conduct, and study reporting. Results Minimum requirements for experimental design and conduct were agreed upon across the dimensions of animal characteristics, sample size calculations, inclusion and exclusion criteria, random allocation to groups, allocation concealment, and blinded assessment of outcome. Building upon the Animals in Research: Reportingin vivo Experiments (ARRIVE) guidelines, reporting standards were developed for pre-clinical studies of pain. These include specific recommendations for reporting on ethical issues, experimental design and conduct, and data analysis and interpretation. Key principles such as sample size calculation, a priori definition of a primary efficacy measure, randomization, allocation concealments, and blinding are discussed. In addition, considerations of how stress and normal rodent physiology impact outcome of analgesic drug studies are considered. Flow diagrams are standard requirements in all clinical trials, and flow diagrams for preclinical trials, which describe number of animals included/excluded, and reasons for exclusion are proposed. Creation of a trial registry for pre-clinical studies focused on drug development in order to estimate possible publication bias is discussed. Conclusions More systematic research is needed to analyze how inadequate internal validity and/or experimental bias may impact reproducibility across pre-clinical pain studies. Addressing the potential threats to internal validity and the sources of experimental biases, as well as increasing the transparency in reporting, are likely to improve preclinical research broadly by ensuring relevant progress is made in advancing the knowledge of chronic pain pathophysiology and identifying novel analgesics. Implications We are now disseminating these Europain processes for discussion in the wider pain research community. Any benefit from these guidelines will be dependent on acceptance and disciplined implementation across pre-clinical laboratories, funding agencies and journal editors, but it is anticipated that these guidelines will be a first step towards improving scientific rigor across the field of pre-clinical pain research.

Randomized trials published in Chinese or Western journals: comparative empirical analysis.

PubMed

Purgato, Marianna; Cipriani, Andrea; Barbui, Corrado

2012-06-01

A major concern to the inclusion in systematic reviews of studies originating in China and published in Chinese journals refers to the quality of study reporting. In this systematic survey of randomized trials, we compared the characteristics of studies published in Chinese journals with those of studies published in Western journals. We included 69 studies comparing citalopram with other antidepressant drugs in the treatment of major depression. Of these, 37 (54%) were published in Chinese journals. The standard of reporting was generally poor in both Western and Chinese studies. In some Chinese studies, the generation of the randomization sequence raised concern about their experimental nature, and in almost all included studies, the concealment of allocation was not properly described. Blinding was seldom adopted in Chinese studies, and the risk of sponsorship bias was uncertain because Chinese studies did not report any financial support. In most Western studies, outcome data were selectively and incompletely reported. Pooling together all trials revealed that citalopram was similarly effective in comparison with all other antidepressant drugs both in Western studies (standardized mean difference, -0.04; 95% confidence interval, -0.15 to 0.06) and in Chinese studies (standardized mean difference, -0.08, 95% confidence interval, -0.18 to 0.02). Randomized controlled trials published in Chinese journals represent most of the studies included in this review. This suggests that omitting to search biomedical databases originating from China would systematically exclude a relevant proportion of randomized trials published in Chinese journals, with a risk of random error or bias. The increasing inclusion of Chinese studies in systematic reviews reinforces the need to check the quality of randomized trials that are meta-analyzed.

Antibiotics for preventing suppurative complications from undifferentiated acute respiratory infections in children under five years of age.

PubMed

Alves Galvão, Márcia G; Rocha Crispino Santos, Marilene Augusta; Alves da Cunha, Antonio J L

2016-02-29

Undifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications. To assess the effectiveness and safety of antibiotics in preventing bacterial complications in children aged two months to 59 months with undifferentiated ARIs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to August week 1, 2015) and EMBASE (1974 to August 2015). Randomised controlled trials (RCTs) or quasi-RCTs comparing antibiotic prescriptions with placebo or no treatment in children aged two months to 59 months with an undifferentiated ARI for up to seven days. Two review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures. We identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.The use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.Ampicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated, so the possibility of reporting bias could not be ruled out.Harm outcomes could not be analysed as they were expressed only in percentages.We found no studies assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death. There is insufficient evidence for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.

Benzodiazepines for delirium.

PubMed

Lonergan, Edmund; Luxenberg, Jay; Areosa Sastre, Almudena

2009-10-07

Delirium occurs in 30% of hospitalised patients and is associated with prolonged hospital stay and increased morbidity and mortality. The results of uncontrolled studies have been unclear, with some suggesting that benzodiazepines may be useful in controlling non-alcohol related delirium. To determine the effectiveness and incidence of adverse effects of benzodiazapines in the treatment of non-alcohol withdrawal related delirium. The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 26 February 2008 using the search terms: (deliri* or confusion) and (benzo* or lorazepam," or "alprazolam" or "ativan" or diazepam or valium or chlordiazepam).The CDCIG Specialized Register contains records from major health databases (including MEDLINE, EMBASE, CINAHL, PsycINFO, CENTRAL, LILACS) as well as many ongoing trial databases and grey literature sources. Trials had to be unconfounded, randomized and with concealed allocation of subjects. Additionally, selected trials had to have assessed patients pre- and post-treatment. Where crossover design was present, only data from the first part of the trial were to be examined. Two reviewers extracted data from included trials. Data were pooled where possible, and were to be analysed using appropriate statistical methods. Odd ratios or average differences were to be calculated. Only "intention to treat" data were to be included. Only one trial satisfying the selection criteria could be identified. In this trial, comparing the effect of the benzodiazepine, lorazepam, with dexmedetomidine, a selective alpha-2-adrenergic receptor agonist, on delirium among mechanically ventilated intensive care unit patients, dexmedetomidine treatment was associated with an increased number of delirium- and coma-free days compared with lorazepam treated patients (dexmedetomidine patients, average seven days; lorazepam patients, average three days; P = 0.01). One partially controlled study showed no advantage of a benzodiazepine (alprazolam) compared with neuroleptics in treating agitation associated with delirium, and another partially controlled study showed decreased effectiveness of a benzodiazepine (lorazepam), and increased adverse effects, compared with neuroleptics (haloperidol, chlorpromazine) for the treatment of acute confusion. No adequately controlled trials could be found to support the use of benzodiazepines in the treatment of non-alcohol withdrawal related delirium among hospitalised patients, and at this time benzodiazepines cannot be recommended for the control of this condition. Because of the scarcity of trials with randomization of patients, placebo control, and adequate concealment of allocation of subjects, it is clear that further research is required to determine the role of benzodiazepines in the treatment of non-alcohol withdrawal related delirium.

Benzodiazepines for delirium.

PubMed

Lonergan, Edmund; Luxenberg, Jay; Areosa Sastre, Almudena; Wyller, Torgeir Bruun

2009-01-21

Delirium occurs in 30% of hospitalised patients and is associated with prolonged hospital stay and increased morbidity and mortality. The results of uncontrolled studies have been unclear, with some suggesting that benzodiazepines may be useful in controlling non-alcohol related delirium. To determine the effectiveness and incidence of adverse effects of benzodiazapines in the treatment of non-alcohol withdrawal related delirium. The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 26 February 2008 using the search terms: (deliri* or confusion) and (benzo* or lorazepam," or "alprazolam" or "ativan" or diazepam or valium or chlordiazepam).The CDCIG Specialized Register contains records from major health databases (including MEDLINE, EMBASE, CINAHL, PsycINFO, CENTRAL, LILACS) as well as many ongoing trial databases and grey literature sources. Trials had to be unconfounded, randomized and with concealed allocation of subjects. Additionally, selected trials had to have assessed patients pre- and post-treatment. Where crossover design was present, only data from the first part of the trial were to be examined. Two reviewers extracted data from included trials. Data were pooled where possible, and were to be analysed using appropriate statistical methods. Odd ratios or average differences were to be calculated. Only "intention to treat" data were to be included. Only one trial satisfying the selection criteria could be identified. In this trial, comparing the effect of the benzodiazepine, lorazepam, with dexmedetomidine, a selective alpha-2-adrenergic receptor agonist, on delirium among mechanically ventilated intensive care unit patients, dexmedetomidine treatment was associated with an increased number of delirium- and coma-free days compared with lorazepam treated patients (dexmedetomidine patients, average seven days; lorazepam patients, average three days; P = 0.01). One partially controlled study showed no advantage of a benzodiazepine (alprazolam) compared with neuroleptics in treating agitation associated with delirium, and another partially controlled study showed decreased effectiveness of a benzodiazepine (lorazepam), and increased adverse effects, compared with neuroleptics (haloperidol, chlorpromazine) for the treatment of acute confusion. No adequately controlled trials could be found to support the use of benzodiazepines in the treatment of non-alcohol withdrawal related delirium among hospitalised patients, and at this time benzodiazepines cannot be recommended for the control of this condition. Because of the scarcity of trials with randomization of patients, placebo control, and adequate concealment of allocation of subjects, it is clear that further research is required to determine the role of benzodiazepines in the treatment of non-alcohol withdrawal related delirium.

Effect of adding upper limb rehabilitation to botulinum toxin-A on upper limb activity after stroke: Protocol for the InTENSE trial.

PubMed

Lannin, Natasha A; Ada, Louise; English, Coralie; Ratcliffe, Julie; Crotty, Maria

2018-01-01

Rationale Although clinical practice guidelines recommend that management of moderate to severe spasticity include the use of botulinum toxin-A in conjunction with therapy, there is currently no evidence to support the addition of therapy. Aims To determine the effect and cost-benefit of adding evidence-based movement training to botulinum toxin-A. Sample size estimate A total of 136 participants will be recruited in order to be able to detect a between-group difference of seven points on the Goal Attainment Scale T-score with 80% power at a two-tailed significance level of 0.05. Methods and design The InTENSE trial is a national, multicenter, Phase III randomized trial with concealed allocation, blinded assessment and intention-to-treat analysis. Stroke survivors who are scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke greater than three months ago, who have completed formal rehabilitation and have no significant cognitive impairment will be randomly allocated to receive botulinum toxin-A plus evidence-based movement training or botulinum toxin-A alone. Study outcomes The primary outcomes are goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at three months (end of intervention) and at 12 months (beyond the intervention). Secondary outcomes are spasticity, range of motion, strength, pain, burden of care and health-related quality of life. Direct costs, personal costs and health system costs will be collected at 12 months. Discussion The results of the InTENSE trial are anticipated to directly influence intervention for moderate to severe spasticity after stroke. Trial Registration ANZCTR12615000616572.

Quality of Reporting Randomized Controlled Trials in Five Leading Neurology Journals in 2008 and 2013 Using the Modified "Risk of Bias" Tool.

PubMed

Zhai, Xiao; Cui, Jin; Wang, Yiran; Qu, Zhiquan; Mu, Qingchun; Li, Peiwen; Zhang, Chaochao; Yang, Mingyuan; Chen, Xiao; Chen, Ziqiang; Li, Ming

2017-03-01

To examine the risk of bias of methodological quality of reporting randomized clinical trials (RCTs) in major neurology journals before and after the update (2011) of Cochrane risk of bias tool. RCTs in 5 leading neurology journals in 2008 and 2013 were searched systematically. Characteristics were extracted based on the list of the modified Cochrane Collaboration's tool. Country, number of patients, type of intervention, and funding source also were examined for further analysis. A total of 138 RCTs were enrolled in this study. The rates of following a trial plan were 61.6% for the allocation generation, 52.9% for the allocation concealment, 84.8% for the blinding of the participants or the personnel, 34.8% for the blinding of outcome assessment, 78.3% for the incomplete outcome data, and 67.4% for the selective reporting. A significant setback was found in "the selective reporting" in 2013 than that in 2008. Trials performed by multi-centers and on a large scale had significantly more "low risk of bias" trials. Not only the number of surgical trials (5.8%) was much less than that of trials using drugs (73.9%), but also the reporting quality of surgical trials were worse (P = 0.008). Finally, only 17.4% trials met the criterion of "low risk of bias." The modified "risk of bias" tool is an improved version for assessment. Methodological quality of reporting RCTs in the 5neurology journals is unsatisfactory, especially that for surgical RCTs, and it could be further improved. Copyright © 2017 Elsevier Inc. All rights reserved.

Day-of-Surgery Mobilization Reduces the Length of Stay After Elective Hip Arthroplasty.

PubMed

Okamoto, Taro; Ridley, Ryan J; Edmondston, Stephen J; Visser, Mariet; Headford, Julie; Yates, Piers J

2016-10-01

To determine the effect of mobilization on the day of surgery on the readiness for discharge and length of stay after elective total hip arthroplasty (THA). We devised a randomized control trial with concealed allocation and intention-to-treat analysis. Overall, 126 patients who underwent THA and met the criteria for mobilization on the day of surgery were randomly allocated into 2 groups; the intervention group was mobilized on the day of surgery, n = 58 and the control group was mobilized on the day after surgery, n = 68. Apart from timing of mobilization, both groups received the same postoperative management. The primary outcome measures were length of hospital stay and time to readiness for discharge. The early mobilization group was ready for discharge 63 hours (standard deviation [SD] = 15 hours) after surgery, compared to 70 hours (SD = 18 hours) for the control group (P = .03, 95% CI, 0.7-12.8). There was no significant difference in hospital stay in the early mobilization group (77 hours [SD = 30 hours]), compared to the control group (87 hours [SD = 35 hours]; P = .11, 95% CI, -2.1 to 21.6). Despite this at any point in time after the surgery, the intervention group was 1.8 times (P = .003, 95% CI, = 1.2-2.7) more likely to have been discharged. Mobilization on the day of THA surgery significantly increases the probability of discharge at any singular point in time compared with mobilization on the day after surgery and decreases the time to readiness for discharge. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Psychosocial effects of workplace physical exercise among workers with chronic pain: Randomized controlled trial.

PubMed

Andersen, Lars L; Persson, Roger; Jakobsen, Markus D; Sundstrup, Emil

2017-01-01

While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain.The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard deviation (SD) 10]) with upper limb chronic musculoskeletal pain were randomly allocated to group-based strength training (physical exercise group) or individual ergonomic training and education (reference group) for 10 weeks. Social climate was assessed with the General Nordic Questionnaire for Psychological and Social Factors at Work, and vitality and mental health were assessed with the 36-item Short Form Health Survey. All scales were converted to 0 to 100 (higher scores are better). Between-group differences from baseline to follow-up were determined using linear mixed models adjusted for workplace, age, gender, and baseline values of the outcome.Mean baseline scores of social climate, mental health, and vitality were 52.2 (SD 14.9), 79.5 (SD 13.7), and 53.9 (SD 19.7), respectively. Complete baseline and follow-up data were obtained from 30 and 31 from the physical exercise and reference groups, respectively. The between-group differences from baseline to follow-up between physical exercise and reference were 7.6 (95% CI 0.3 to 14.9), -2.3 (95% CI -10.3 to 5.8), and 10.1 (95% CI 0.6 to 19.5) for social climate, mental health, and vitality, respectively. For social climate and vitality, this corresponded to moderate effect sizes (Cohen d = 0.51 for both) in favor of physical exercise. There were no reported adverse events.In conclusion, workplace physical exercise performed together with colleagues improves social climate and vitality among workers with chronic musculoskeletal pain. Mental health remained unchanged.

Slow versus rapid maxillary expansion in bilateral cleft lip and palate: a CBCT randomized clinical trial.

PubMed

de Almeida, Araci Malagodi; Ozawa, Terumi Okada; Alves, Arthur César de Medeiros; Janson, Guilherme; Lauris, José Roberto Pereira; Ioshida, Marilia Sayako Yatabe; Garib, Daniela Gamba

2017-06-01

The purpose of this "two-arm parallel" trial was to compare the orthopedic, dental, and alveolar bone plate changes of slow (SME) and rapid (RME) maxillary expansions in patients with complete bilateral cleft lip and palate (BCLP). Forty-six patients with BCLP and maxillary arch constriction in the late mixed dentition were randomly and equally allocated into two groups. Computer-generated randomization was used. Allocation was concealed with sequentially, numbered, sealed, opaque envelopes. The SME and RME groups comprised patients treated with quad-helix and Haas/Hyrax-type expanders, respectively. Cone-beam computed tomography (CBCT) exams were performed before expansion and 4 to 6 months post-expansion. Nasal cavity width, maxillary width, alveolar crest width, arch width, palatal cleft width, inclination of posterior teeth, alveolar crest level, and buccal and lingual bone plate thickness were assessed. Blinding was applicable for outcome assessment only. Interphase and intergroup comparisons were performed using paired t tests and t tests, respectively (p < 0.05). SME and RME similarly promoted significant increase in all the maxillary transverse dimensions at molar and premolar regions with a decreasing expanding effect from the dental arch to the nasal cavity. Palatal cleft width had a significant increase in both groups. Significant buccal inclination of posterior teeth was only observed for RME. Additionally, both expansion procedures promoted a slight reduction of the alveolar crest level and the buccal bone plate thickness. No difference was found between the orthopedic, dental, and alveolar bone plate changes of SME and RME in children with BCLP. Both appliances produced significant skeletal transverse gains with negligible periodontal bone changes. Treatment time for SME, however, was longer than the observed for RME. SME and RME can be similarly indicated to correct maxillary arch constriction in patients with BCLP in the mixed dentition.

Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial.

PubMed

Price, Anna M H; Wake, Melissa; Ukoumunne, Obioha C; Hiscock, Harriet

2012-10-01

Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P = .8) and conduct behavior scores (P = .6), sleep problems (9% vs 7%, P = .2), sleep habits score (P = .4), parent- (P = .7) and child-reported (P = .8) psychosocial functioning, chronic stress (29% vs 22%, P = .4); (2) child-parent closeness (P = .1) and conflict (P = .4), global relationship (P = .9), disinhibited attachment (P = .3); and (3) parent depression, anxiety, and stress scores (P = .9) or authoritative parenting (63% vs 59%, P = .5). Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.

PubMed

Mhaskar, Rahul; Djulbegovic, Benjamin; Magazin, Anja; Soares, Heloisa P; Kumar, Ambuj

2012-06-01

To assess whether the reported methodological quality of randomized controlled trials (RCTs) reflects the actual methodological quality and to evaluate the association of effect size (ES) and sample size with methodological quality. Systematic review. This is a retrospective analysis of all consecutive phase III RCTs published by eight National Cancer Institute Cooperative Groups up to 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. Four hundred twenty-nine RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94; 95% confidence interval [CI]: 0.88, 0.99) and 24% (RHR: 1.24; 95% CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. The largest study to date shows that poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results. Copyright © 2012 Elsevier Inc. All rights reserved.

Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial.

PubMed

Lucassen, Mathijs F G; Stasiak, Karolina; Crengle, Sue; Weisz, John R; Frampton, Christopher M A; Bearman, Sarah Kate; Ugueto, Ana M; Herren, Jennifer; Cribb-Su'a, Ainsleigh; Faleafa, Monique; Kingi-'Ulu'ave, Denise; Loy, Jik; Scott, Rebecca M; Hartdegen, Morgyn; Merry, Sally N

2015-10-12

Mental health disorders are common and disabling for young people because of the potential to disrupt key developmental tasks. Implementation of evidence-based psychosocial therapies in New Zealand is limited, owing to the inaccessibility, length, and cost of training in these therapies. Furthermore, most therapies address one problem area at a time, although comorbidity and changing clinical needs commonly occur in practice. A more flexible approach is needed. The Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC) is designed to overcome these challenges; it provides a range of treatment modules addressing different problems, within a single training program. A clinical trial of MATCH-ADTC in the USA showed that MATCH-ADTC outperformed usual care and standard evidence-based treatment on several clinical measures. We aim to replicate these findings and evaluate the impact of providing training and supervision in MATCH-ADTC to: (1) improve clinical outcomes for youth attending mental health services; (2) increase the amount of evidence-based therapy content; (3) increase the efficiency of service delivery. This is an assessor-blinded multi-site effectiveness randomized controlled trial. Randomization occurs at two levels: (1) clinicians (≥60) are randomized to intervention or usual care; (2) youth participants (7-14 years old) accepted for treatment in child and adolescent mental health services (with a primary disorder that includes anxiety, depression, trauma-related symptoms, or disruptive behavior) are randomly allocated to receive MATCH-ADTC or usual care. Youth participants are recruited from 'mainstream', Māori-specific, and Pacific-specific child and adolescent mental health services. We originally planned to recruit 400 youth participants, but this has been revised to 200 participants. Centralized computer randomization ensures allocation concealment. The primary outcome measures are: (i) the difference in trajectory of change of clinical severity between groups (using the parent-rated Brief Problem Monitor); (ii) clinicians' use of evidence-based treatment procedures during therapy sessions; (iii) total time spent by clinicians delivering therapy. If MATCH-ADTC demonstrates effectiveness it could offer a practical efficient method to increase access to evidence-based therapies, and improve outcomes for youth attending secondary care services. Australian and New Zealand Clinical Trials Registry ACTRN12614000297628 .

Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer's disease: study protocol of a randomized controlled trial (The FIT-AD trial).

PubMed

Yu, Fang; Bronas, Ulf G; Konety, Suma; Nelson, Nathaniel W; Dysken, Maurice; Jack, Clifford; Wyman, Jean F; Vock, David; Smith, Glenn

2014-10-11

Alzheimer's disease, a global public health issue, accounts for 60 to 80% of all dementias. Alzheimer's disease primarily causes cognitive impairment and drugs have only modest short-term effects, highlighting a pressing need to develop effective interventions. Aerobic exercise holds promise for treating cognitive impairment in Alzheimer's disease through biologically sound mechanisms. Nonetheless, aerobic exercise studies in Alzheimer's disease are limited with mixed findings. This pilot randomized controlled trial will investigate the effects of a 6-month, individualized, moderate-intensity cycling intervention (20 to 50 minutes per session, 3 times a week) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer's disease. The specific aims are to: 1) determine the immediate effect of the cycling intervention on cognition in Alzheimer's disease; 2) examine if the cycling intervention slows cognitive decline in Alzheimer's disease from baseline to 12 months; and 3) assess the effect of aerobic exercise on hippocampal volume over 12 months. Ninety subjects will be randomized on a 2:1 allocation ratio to cycling or attention control (low-intensity stretching) and followed for another 6 months. Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data. Cognition will be measured by the Alzheimer's disease Assessment Scale-Cognition at baseline before randomization and at 3, 6, 9, and 12 months. Hippocampal volume will be measured by magnetic resonance imaging at baseline and 6 and 12 months. The sample size of 90 will give 80% power to detect a 2.5-point difference in within-group changes in the Alzheimer's disease Assessment Scale-Cognition at 6 months for the cycling group. Findings from this study will address the critical gap of exercise efficacy in Alzheimer's disease and use of magnetic resonance imaging as an outcome measure in clinical trials. This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population. Primary registration: (NCT01954550; date of registration: 20 September 2013). Secondary registration: (NCT01954550; date of registration: 1 October 2013).

Internet-Based Assessment of Oncology Health Care Professional Learning Style and Optimization of Materials for Web-Based Learning: Controlled Trial With Concealed Allocation

PubMed Central

Micheel, Christine M; Anderson, Ingrid A; Lee, Patricia; Chen, Sheau-Chiann; Justiss, Katy; Giuse, Nunzia B; Ye, Fei; Kusnoor, Sheila V

2017-01-01

Background Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies. Objective This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning. Methods In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment. Results A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02). Conclusions Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content. PMID:28743680

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

PubMed

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

Effect of pumping pressure on onset of lactation after caesarean section: A randomized controlled study.

PubMed

Zhang, Feng; Yang, Yahui; Bai, Ting; Sun, Lele; Sun, Mingzhu; Shi, Xueling; Zhu, Meng; Ge, Meijuan; Xia, Haiou

2018-01-01

Caesarean section is associated with weaker newborn suction pressure. This nonblinded, randomized trial explored the effect of suction pressures generating by a breast pump on mothers' onset of lactation and milk supply after caesarean section. A high pressure group (-150 mmHg), a low pressure group (-100 mmHg), and a control group (none) were generated under computer random assignment with concealed allocation in 2 tertiary hospitals. The breast pumping began within 2 hr after caesarean operation (6 times a day and 30 min per time) until onset of lactation. The primary outcomes were the timing of onset of lactation, milk supply, and mother's satisfaction in lactation, using both intention-to-treat and per-protocol analyses. The secondary endpoints were the pumping-related pain, nipple injury, and maternal fatigue. All 164 women randomized were included in analysis. The breast pumping at -150 mmHg optimally advanced the timing of the onset of lactation and increased daytime milk supply. The pumping also appeared to boost mothers' confidence in lactation. The results in the per-protocol population (n = 148) were consistent with those of intention-to-treat population (n = 164). However, the pumping aggravated maternal nipple pain and fatigue, though there was no statistical significance. The findings suggest that a higher pumping pressure within the range of normal vaginally born infant suction could promote onset of lactation and milk supply among mothers giving birth by caesarean section. The pumping could also enhance mothers' confidence in breastfeeding. © 2017 John Wiley & Sons Ltd.

How to Do Random Allocation (Randomization)

PubMed Central

Shin, Wonshik

2014-01-01

Purpose To explain the concept and procedure of random allocation as used in a randomized controlled study. Methods We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper. PMID:24605197

Teaching Medical Ethics in Graduate and Undergraduate Medical Education: A Systematic Review of Effectiveness.

PubMed

de la Garza, Santiago; Phuoc, Vania; Throneberry, Steven; Blumenthal-Barby, Jennifer; McCullough, Laurence; Coverdale, John

2017-08-01

One objective was to identify and review studies on teaching medical ethics to psychiatry residents. In order to gain insights from other disciplines that have published research in this area, a second objective was to identify and review studies on teaching medical ethics to residents across all other specialties of training and on teaching medical students. PubMed, EMBASE, and PsycINFO were searched for controlled trials on teaching medical ethics with quantitative outcomes. Search terms included ethics, bioethics, medical ethics, medical students, residents/registrars, teaching, education, outcomes, and controlled trials. Nine studies were found that met inclusion criteria, including five randomized controlled trails and four controlled non-randomized trials. Subjects included medical students (5 studies), surgical residents (2 studies), internal medicine house officers (1 study), and family medicine preceptors and their medical students (1 study). Teaching methods, course content, and outcome measures varied considerably across studies. Common methodological issues included a lack of concealment of allocation, a lack of blinding, and generally low numbers of subjects as learners. One randomized controlled trial which taught surgical residents using a standardized patient was judged to be especially methodologically rigorous. None of the trials incorporated psychiatry residents. Ethics educators should undertake additional rigorously controlled trials in order to secure a strong evidence base for the design of medical ethics curricula. Psychiatry ethics educators can also benefit from the findings of trials in other disciplines and in undergraduate medical education.

Ecologically optimizing exercise maintenance in men and women post-cardiac rehabilitation: Protocol for a randomized controlled trial of efficacy with economics (ECO-PCR).

PubMed

Reid, Robert; Blanchard, Chris M; Wooding, Evyanne; Harris, Jennifer; Krahn, Murray; Pipe, Andrew; Chessex, Caroline; Grace, Sherry L

2016-09-01

Exercise-based cardiac rehabilitation (CR) participation results in increased cardio-metabolic fitness, which is associated with reduced mortality. However, many graduates fail to maintain exercise post-program. ECO-PCR investigates the efficacy and cost-effectiveness of a social ecologically-based intervention to increase long-term exercise maintenance following the completion of CR. A three-site, 2-group, parallel randomized controlled trial is underway. 412 male and 192 female (N=604) supervised CR participants are being recruited just before CR graduation. Participants are randomized (1:1 concealed allocation) to intervention or usual care. A 50-week exercise facilitator intervention has been designed to assist CR graduates in the transition from structured, supervised exercise to self-managed home- or community-based (e.g., Heart Wise Exercise programs) exercise. The intervention consists of 8 telephone contacts over the 50week period: 3 individual and 5 group. Assessments occur at CR graduation, and 26, 52 and 78weeks post-randomization. The primary outcome is change in minutes of accelerometer-measured moderate to vigorous-intensity physical activity (MVPA) from CR graduation to 52weeks post-randomization. Secondary measures include exercise capacity, quality of life, and cardiovascular risk factors. Analyses will be undertaken based on intention-to-treat. For the primary outcome, an analysis of variance will be computed to test the change in minutes of MVPA in each group between CR graduation and 52week follow-up (2 [arm]×2 [time]). Secondary objectives will be assessed using mixed-model repeated measures analyses to compare differences between groups over time. Mean costs and quality-adjusted life years for each arm will be estimated. Copyright © 2016 Elsevier Inc. All rights reserved.

Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.

PubMed

Gohari, Faeze; Baradaran, Hamid Reza; Tabatabaee, Morteza; Anijidani, Shabnam; Mohammadpour Touserkani, Fatemeh; Atlasi, Rasha; Razmgir, Maryam

2015-01-01

To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Systematized review. We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting. One hundred and eight five (185) studies were included and appraised. Half of them (55.7 %) were published in Iranian journals. Most (89.7 %) were parallel RCTs, and being performed on type2 diabetic patients (77.8 %). Less than half of the CONSORT items (43.2 %) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1 % mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8 % of trials report how blinding was applied. The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.

Photonic generation of polarization-resolved wideband chaos with time-delay concealment in three-cascaded vertical-cavity surface-emitting lasers.

PubMed

Liu, Huijie; Li, Nianqiang; Zhao, Qingchun

2015-05-10

Optical chaos generated by chaotic lasers has been widely used in several important applications, such as chaos-based communications and high-speed random-number generators. However, these applications are susceptible to degradation by the presence of time-delay (TD) signature identified from the chaotic output. Here we propose to achieve the concealment of TD signature, along with the enhancement of chaos bandwidth, in three-cascaded vertical-cavity surface-emitting lasers (VCSELs). The cascaded system is composed of an external-cavity master VCSEL, a solitary intermediate VCSEL, and a solitary slave VCSEL. Through mapping the evolutions of TD signature and chaos bandwidth in the parameter space of the injection strength and frequency detuning, photonic generation of polarization-resolved wideband chaos with TD concealment is numerically demonstrated for wide regions of the injection parameters.

Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial.

PubMed

2017-11-01

CT radiation is arguably carcinogenic. Results from single-centre studies, mostly retrospective, have advocated lowering the CT radiation dose for the diagnosis of appendicitis. However, adoption of low-dose CT has been slow. We aimed to assess the effectiveness of low-dose CT compared with standard-dose CT in the diagnosis of appendicitis in adolescents and young adults. We did this pragmatic, multicentre, randomised controlled non-inferiority trial at 20 South Korean teaching hospitals with little experience with low-dose CT. Patients aged 15-44 years with suspected appendicitis were randomly assigned (1:1), via computer-generated random assignments (permuted block sizes of two, four, six, and eight) concealed in sequentially numbered envelopes, to receive low-dose CT (2 mSv) or standard-dose CT (≤8 mSv). Randomisation was stratified by site. Group allocation was concealed from patients, outcome assessors, and adverse event adjudicators; care providers, site pathologists, and data collectors were aware of allocation. The primary endpoint was the negative (unnecessary) appendectomy rate among all appendectomies, with a non-interiority margin of 4·5% for low-dose versus standard-dose CT. Primary analysis was by modified intention to treat, which included all patients who received an appendectomy in the group to which they were assigned. This trial is registered with ClinicalTrials.gov, number NCT01925014. Between Dec 4, 2013, and Aug 18, 2016, we assigned 1535 patients to the low-dose CT group and 1539 patients to the standard-dose CT group. 22 (3·9%) of 559 patients had a negative appendectomy in the low-dose group versus 16 (2·7%) of 601 patients in the standard-dose group (difference 1·3%, 95% CI -0·8 to 3·3; p=0·0022 for the non-inferiority test). We recorded 43 adverse events in 43 (2·8%) of 1535 patients in the low-dose group and 41 adverse events in 40 (2·6%) of 1539 patients in the standard-dose group. One life-threatening adverse event of anaphylaxis caused by an iodinated contrast material occurred in the low-dose group. Radiation dose of appendiceal CT for adolescents and young adults can be reduced to 2 mSv without impairing clinical outcomes. In view of the vast number of appendiceal CT examinations done worldwide, use of low-dose CT could prevent a sizeable number of radiation-associated cancers in the future. Korea Health Industry Development Institute, Seoul National University Bundang Hospital, Dasol Life Science, and Bracco Imaging Korea. Copyright © 2017 Elsevier Ltd. All rights reserved.

Wide brick tunnel randomization - an unequal allocation procedure that limits the imbalance in treatment totals.

PubMed

Kuznetsova, Olga M; Tymofyeyev, Yevgen

2014-04-30

In open-label studies, partial predictability of permuted block randomization provides potential for selection bias. To lessen the selection bias in two-arm studies with equal allocation, a number of allocation procedures that limit the imbalance in treatment totals at a pre-specified level but do not require the exact balance at the ends of the blocks were developed. In studies with unequal allocation, however, the task of designing a randomization procedure that sets a pre-specified limit on imbalance in group totals is not resolved. Existing allocation procedures either do not preserve the allocation ratio at every allocation or do not include all allocation sequences that comply with the pre-specified imbalance threshold. Kuznetsova and Tymofyeyev described the brick tunnel randomization for studies with unequal allocation that preserves the allocation ratio at every step and, in the two-arm case, includes all sequences that satisfy the smallest possible imbalance threshold. This article introduces wide brick tunnel randomization for studies with unequal allocation that allows all allocation sequences with imbalance not exceeding any pre-specified threshold while preserving the allocation ratio at every step. In open-label studies, allowing a larger imbalance in treatment totals lowers selection bias because of the predictability of treatment assignments. The applications of the technique in two-arm and multi-arm open-label studies with unequal allocation are described. Copyright © 2013 John Wiley & Sons, Ltd.

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials.

PubMed

Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

2004-04-15

Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis.

Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

PubMed Central

Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

2004-01-01

Background Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. Methods RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. Results The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting. Conclusion There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis. PMID:15086953

A systematic review of RCTs and quasi-RCTs on traditional Chinese patent medicines for treatment of chronic hepatitis B.

PubMed

Zhan, Tao; Wei, Xing; Chen, Ze-Qi; Wang, Dong-Sheng; Dai, Xing-Ping

2011-12-01

Traditional Chinese patent medicines (TCPMs) are widely used for treatment of chronic hepatitis B (CHB) in China. To estimate the overall effectiveness of TCPMs for CHB, we performed a systematic review of clinical reports designed as randomized controlled trials (RCTs). One hundred and thirty-eight available RCTs and quasi-RCTs on 62 TCPMs, involving 16,393 patients, were included. The methodological quality of these trials was generally "poor". Few trials (6.52%) reported the methods of randomization correctly. Another common problem was the lack of allocation concealment, proper blinding, and the reporting of lost cases and dropouts. Forty-two trials (30.43%) on 27 TCPMs reported some anti-viral effect of TCPMs. Others reported beneficial aspects, including improvements of liver function (79.71% of the studies), liver fibrosis (29.99%), and CHB symptoms (92.75%). Forty-one articles (29.71%) reported mild adverse events with TCPMs but these occurred infrequently. In summary, the outcome of the report on currently registered TCPMs may be biased due to poor methodology. The data from these trials, therefore, is too weak to use in forming a recommendation for treatment of CHB. Nevertheless, five drugs (Dan Shen agents, Da Huang Zhe Chong pill/capsule, Shuang Hu Qing Gan granule, Fu Zheng Hua Yu granule and Cao Xian Yi Gan capsule) appear to be more effective than the other TCPMs.

Early double J stent removal in renal transplant patients to prevent urinary tract infection - systematic review and meta-analysis of randomized controlled trials.

PubMed

Yahav, Dafna; Green, Hefziba; Eliakim-Raz, Noa; Mor, Eytan; Husain, Shahid

2018-04-01

Ureteral stents are routinely used in renal transplant and are associated with reduced urological complications but increased urinary tract infections (UTIs). There is no agreement on the preferred time to removal of stents after transplantation. We performed a systematic review and meta-analysis of all randomized controlled trials (RCTs) comparing stent duration of <14 days vs > =14 days. Electronic databases were searched to identify RCTs that compared early vs late stent removal. Primary outcome was urinary tract infections. Secondary outcomes included various urological complications. No significant difference in UTI rates was demonstrated between short and long stent duration (relative risk (RR) 0.85, 95% confidence interval (CI) 0.44-1.64), with significant heterogeneity (I 2  = 86%). Sensitivity analysis evaluating studies with low risk of bias for allocation concealment demonstrated statistically significant lower rates of UTI with short stent duration (RR 0.48, 95% CI 0.32-0.71) with no heterogeneity. No significant difference was demonstrated for the outcome of major urological complications (RR 0.72, 95% CI 0.50-1.05), without heterogeneity. Ureteral stenosis rates were significantly lower in the short duration arm (RR 0.42, 95% CI 0.18-0.98). Early removal of ureteral stents after renal transplant may be associated with reduced rates of UTI and ureteral stenosis. Additional RCTs are needed.

Use of a fermented dairy probiotic drink containing Lactobacillus casei (DN-114 001) to decrease the rate of illness in kids: the DRINK study. A patient-oriented, double-blind, cluster-randomized, placebo-controlled, clinical trial.

PubMed

Merenstein, D; Murphy, M; Fokar, A; Hernandez, R K; Park, H; Nsouli, H; Sanders, M E; Davis, B A; Niborski, V; Tondu, F; Shara, N M

2010-07-01

To evaluate whether a fermented dairy drink containing the probiotic strain Lactobacillus casei DN-114 001 could reduce the incidence of common infectious diseases (CIDs) and the change of behavior because of illness in children. We conducted a double-blinded, randomized, placebo-controlled allocation concealment clinical trial in the Washington, DC metropolitan area. Participants were 638 children 3-6 years old in daycare/schools. The intervention was a fermented dairy drink containing a specific probiotic strain or matching placebo with no live cultures for 90 consecutive days. Two primary outcomes were assessed: incidence of CIDs and change of behavior because of illness (both assessed by parental report). The rate of change of behavior because of illness was similar among active and control groups. However, the incidence rate for CIDs in the active group (0.0782) is 19% lower than that of the control group (0.0986) (incidence rate ratio=0.81, 95% CI: 0.65, 099) P=0.046. Daily intake of a fermented dairy drink containing the probiotic strain L. casei DN-114 001 showed some promise in reducing overall incidence of illness, but was primarily driven by gastrointestinal infections and there were no differences in change of behavior.

The Effectiveness of Social Robots for Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Studies.

PubMed

Pu, Lihui; Moyle, Wendy; Jones, Cindy; Todorovic, Michael

2018-06-12

Social robots may promote the health of older adults by increasing their perceived emotional support and social interaction. This review aims to summarize the effectiveness of social robots on outcomes (psychological, physiological, quality of life, or medications) of older adults from randomized controlled trials (RCTs). A mixed-method systematic review of RCTs meeting the study inclusion criteria was undertaken. Eight databases were electronically searched up to September 2017. Participants' characteristics, intervention features, and outcome data were retrieved. The mean difference and standardized mean difference with 95% confidence intervals (CI) were synthesized to pool the effect size. A total of 13 articles from 11 RCTs were identified from 2,204 articles, of which 9 studies were included in the meta-analysis. Risk of bias was relatively high in allocation concealment and blinding. Social robots appeared to have positive impacts on agitation, anxiety, and quality of life for older adults but no statistical significance was found in the meta-analysis. However, results from a narrative review indicated that social robot interactions could improve engagement, interaction, and stress indicators, as well as reduce loneliness and the use of medications for older adults. Social robots appear to have the potential to improve the well-being of older adults, but conclusions are limited due to the lack of high-quality studies. More RCTs are recommended with larger sample sizes and rigorous study designs.

Chest compressions in newborn animal models: A review.

PubMed

Solevåg, Anne Lee; Cheung, Po-Yin; Lie, Helene; O'Reilly, Megan; Aziz, Khalid; Nakstad, Britt; Schmölzer, Georg Marcus

2015-11-01

Much of the knowledge about the optimal way to perform chest compressions (CC) in newborn infants is derived from animal studies. The objective of this review was to identify studies of CC in newborn term animal models and review the evidence. We also provide an overview of the different models. MEDLINE, EMBASE and CINAHL, until September 29th 2014. Study eligibility criteria and interventions: term newborn animal models where CC was performed. Based on 419 retrieved studies from MEDLINE and 502 from EMBASE, 28 studies were included. No additional studies were identified in CINAHL. Most of the studies were performed in pigs after perinatal transition without long-term follow-up. The models differed widely in methodological aspects, which limits the possibility to compare and synthesize findings. Studies uncommonly reported the method for randomization and allocation concealment, and a limited number were blinded. Only the evidence in favour of the two-thumb encircling hands technique for performing CC, a CC to ventilation ratio of 3:1; and that air can be used for ventilation during CC; was supported by more than one study. Animal studies should be performed and reported with the same rigor as in human randomized trials. Good transitional and survival models are needed to further increase the strength of the evidence derived from animal studies of newborn chest compressions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204].

PubMed

Cyna, Allan M; Andrew, Marion I; Robinson, Jeffrey S; Crowther, Caroline A; Baghurst, Peter; Turnbull, Deborah; Wicks, Graham; Whittle, Celia

2006-03-05

Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and < 39 weeks gestation, planning a vaginal birth, not in active labour, with a singleton, viable fetus of vertex presentation, are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups commence hypnosis training as near as possible to 37 weeks gestation. Treatment allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women/group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia - the primary endpoint. We estimate that approximately 5-10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women/group and perform sequential interim analyses when 150 and 300 participants have been recruited. All participant data will be analysed, by a researcher blinded to treatment allocation, according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses. If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

A Randomized Trial of a Diet and Exercise Intervention for Overweight and Obese Women from Economically Disadvantaged Neighborhoods: Sisters Taking Action for Real Success (STARS)

PubMed Central

Wilcox, Sara; Sharpe, Patricia A.; Parra-Medina, Deborah; Granner, Michelle; Hutto, Brent

2011-01-01

Background Lower socioeconomic status at both the individual and neighborhood level is associated with increased health risks. Weight loss can reduce this risk, but few high quality weight loss studies target this population. Objectives STARS tests a culturally-appropriate, group-based behavioral and social support intervention on body weight and waist circumference in women from financially disadvantaged neighborhoods. Design A stratified (by BMI) randomized trial. Randomization to group was generated by a random numbers table with allocation concealment by opaque envelopes. Methods Participants 25–50 years who had a BMI ≥ 25 kg/m2 and a waist circumference ≥ 88 cm were recruited from 18 census tracts in Columbia, SC with high rates of poverty between November 2008 and November 2010. All participants received a dietary and exercise counseling session. Intervention participants then receive 16 theoretically-based and tailored weekly group sessions followed by 8 weeks of telephone maintenance counseling. Control participants receive 16 weekly health education mailings. Measurements correspond to baseline, post-group intervention, and post-telephone counseling, and for intervention participants, after a 12-week no-contact period. Measurement staff was blinded to group assignment. Results Participants (N=155; n=80 intervention, n=75 minimal intervention control) were primarily African American (86.5%) and averaged 38.9 years with a mean BMI of 40.1 kg/m2 and waist circumference of 115.4 cm. Food insecurity was reported by 43% of participants. Summary STARS targets an underserved population with an innovative, tailored, and theoretically-grounded, group-based intervention followed by telephone maintenance. If effective, the approach has the potential to be feasible and cost-effective for community delivery. PMID:21864718

Inhaled Cannabis for Chronic Neuropathic Pain: A Meta-analysis of Individual Patient Data.

PubMed

Andreae, Michael H; Carter, George M; Shaparin, Naum; Suslov, Kathryn; Ellis, Ronald J; Ware, Mark A; Abrams, Donald I; Prasad, Hannah; Wilsey, Barth; Indyk, Debbie; Johnson, Matthew; Sacks, Henry S

2015-12-01

Chronic neuropathic pain, the most frequent condition affecting the peripheral nervous system, remains underdiagnosed and difficult to treat. Inhaled cannabis may alleviate chronic neuropathic pain. Our objective was to synthesize the evidence on the use of inhaled cannabis for chronic neuropathic pain. We performed a systematic review and a meta-analysis of individual patient data. We registered our protocol with PROSPERO CRD42011001182. We searched in Cochrane Central, PubMed, EMBASE, and AMED. We considered all randomized controlled trials investigating chronic painful neuropathy and comparing inhaled cannabis with placebo. We pooled treatment effects following a hierarchical random-effects Bayesian responder model for the population-averaged subject-specific effect. Our evidence synthesis of individual patient data from 178 participants with 405 observed responses in 5 randomized controlled trials following patients for days to weeks provides evidence that inhaled cannabis results in short-term reductions in chronic neuropathic pain for 1 in every 5 to 6 patients treated (number needed to treat = 5.6 with a Bayesian 95% credible interval ranging between 3.4 and 14). Our inferences were insensitive to model assumptions, priors, and parameter choices. We caution that the small number of studies and participants, the short follow-up, shortcomings in allocation concealment, and considerable attrition limit the conclusions that can be drawn from the review. The Bayes factor is 332, corresponding to a posterior probability of effect of 99.7%. This novel Bayesian meta-analysis of individual patient data from 5 randomized trials suggests that inhaled cannabis may provide short-term relief for 1 in 5 to 6 patients with neuropathic pain. Pragmatic trials are needed to evaluate the long-term benefits and risks of this treatment. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

Antimicrobial drugs for persistent diarrhoea of unknown or non-specific cause in children under six in low and middle income countries: systematic review of randomized controlled trials

PubMed Central

2009-01-01

Background A high proportion of children with persistent diarrhoea in middle and low income countries die. The best treatment is not clear. We conducted a systematic review to evaluate the effectiveness of antimicrobial drug treatment for persistent diarrhoea of unknown or non-specific cause. Methods We included randomized comparisons of antimicrobial drugs for the treatment of persistent diarrhoea of unknown or non-specific cause in children under the age of six years in low and middle income countries. We searched the electronic databases MEDLINE, EMBASE, LILACS, WEB OF SCIENCE, and the Cochrane Central Register of Controlled Trials (CENTRAL) to May 2008 for relevant randomized or quasi randomized controlled trials. We summarised the characteristics of the eligible trials, assessed their quality using standard criteria, and extracted relevant outcomes data. Where appropriate, we combined the results of different trials. Results Three trials from South East Asia and one from Guatemala were included, all were small, and three had adequate allocation concealment. Two were in patients with diarrhoea of unknown cause, and two were in patients in whom known bacterial or parasitological causes of diarrhoea had been excluded. No difference was demonstrated for oral gentamicin compared with placebo (presence of diarrhoea at 6 or 7 days; 2 trials, n = 151); and for metronidazole compared with placebo (presence of diarrhoea at 3, 5 and 7 days; 1 trial, n = 99). In one small trial, sulphamethoxazole-trimethoprim appeared better than placebo in relation to diarrhoea at seven days and total stool volume (n = 55). Conclusion There is little evidence as to whether or not antimicrobials help treat persistent diarrhoea in young children in low and middle income countries. PMID:19257885

Glucagon-like peptide-1 receptor agonists versus insulin glargine for type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials

PubMed Central

Li, Wei-Xin; Gou, Jian-Feng; Tian, Jin-Hui; Yan, Xiang; Yang, Lin

2010-01-01

Background: Glucagon-like peptide-1 (GLP-1) receptor agonists are a new class of hypoglycemic drugs, including exenatide, liraglutide, albiglutide, lixisenatide, and taspoglutide. Insulin glargine is a standard agent used to supplement basal insulin in type 2 diabetes mellitus (T2DM). Objective: The aim of this study was to review the efficacy and safety profiles of GLP-1 receptor agonists versus insulin glargine in type 2 diabetic patients who have not achieved treatment goals with oral hypoglycemic agents. Methods: The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and the database of ongoing trials were searched from inception through April 2010. Additional data were sought from relevant Web sites, the American Diabetes Association, reference lists of included trials and related (systematic) reviews, and industry. Randomized controlled trials (RCTs) were selected if they were ≥3 months in duration, compared GLP-1 receptor agonists with insulin glargine in patients with T2DM, and included ≥1 of the following outcomes: mortality, complications of T2DM, glycemie control, weight, lipids, blood pressure, adverse effects, and health-related quality of life. Quasirandomized controlled trials were excluded. The quality of the eligible studies was assessed on the basis of the following aspects: randomization procedure, allocation concealment, blinding, incomplete outcome data (intent-to-treat [ITT] analysis), selective outcome reporting, and publication bias. Results: A total of 410 citations were retrieved; 5 multicenter RCTs that met the inclusion criteria were identified. They were all open-label designs with an insulin glargine arm, predefined outcomes reported, and ITT analysis. One trial had an unclear randomization procedure and allocation concealment. Publication bias was not able to be determined. No data wete found with regard to mortality or diabetes-associated complications, and few data were found on quality of life. The results of the metaanalysis suggest that insulin glargine was significantly better in reducing the fasting blood glucose (mean difference [MD] [95% CI], 1.31 [1.04 to 1.58]; P < 0.001), but exhibits greater incidence of nocturnal hypoglycemia (risk ratio [RR] [95% CI], 0.40 [0.23 to 0.71]; P = 0.002) and influenza (RR [95% CI], 0.56 [0.32 to 0.98]; P = 0.04). GLP-1 receptor agonists are more conducive to reducing weight (MD [95% CI], −3.96 [−5.14 to -2.77]; P < 0.001), postprandial blood glucose (after breakfast, P < 0.001; after dinner, P < 0.001), and LDL-C (MD [95% CI], −0.18 [−0.28 to −0.08]; P < 0.001), but have significantly more gastrointestinal adverse effects (eg, nausea/ vomiting, P < 0.001). There were no significant differences between GLP-1 receptor agonists and insulin glargine in reducing glycosylated hemoglobin (HbA1c) levels (MD [95% CI], −0.03 [−0.13 to 0.08]) and the overall incidence of hypoglycemia (RR [95% CI], 0.69 [0.42 to 1.14]). Conclusions: Compared with insulin glargine, GLP-1 receptor agonists did not have a significant difference in regard to reducing HbA1c levels and they were significantly associated with decreased weight but increased gastrointestinal adverse events. It remains unclear whether GLP-1 receptor agonists influence mortality or diabetes-associated complications in patients with T2DM. More trials with longer follow-up are needed to determine the exact long-term efficacy and safety profiles of this new class of hypoglycemic drugs. PMID:24688145

Psychosocial effects of workplace physical exercise among workers with chronic pain

PubMed Central

Andersen, Lars L.; Persson, Roger; Jakobsen, Markus D.; Sundstrup, Emil

2017-01-01

Abstract While workplace physical exercise can help manage musculoskeletal disorders, less is known about psychosocial effects of such interventions. This aim of this study was to investigate the effect of workplace physical exercise on psychosocial factors among workers with chronic musculoskeletal pain. The trial design was a 2-armed parallel-group randomized controlled trial with allocation concealment. A total of 66 slaughterhouse workers (51 men and 15 women, mean age 45 years [standard deviation (SD) 10]) with upper limb chronic musculoskeletal pain were randomly allocated to group-based strength training (physical exercise group) or individual ergonomic training and education (reference group) for 10 weeks. Social climate was assessed with the General Nordic Questionnaire for Psychological and Social Factors at Work, and vitality and mental health were assessed with the 36-item Short Form Health Survey. All scales were converted to 0 to 100 (higher scores are better). Between-group differences from baseline to follow-up were determined using linear mixed models adjusted for workplace, age, gender, and baseline values of the outcome. Mean baseline scores of social climate, mental health, and vitality were 52.2 (SD 14.9), 79.5 (SD 13.7), and 53.9 (SD 19.7), respectively. Complete baseline and follow-up data were obtained from 30 and 31 from the physical exercise and reference groups, respectively. The between-group differences from baseline to follow-up between physical exercise and reference were 7.6 (95% CI 0.3 to 14.9), −2.3 (95% CI -10.3 to 5.8), and 10.1 (95% CI 0.6 to 19.5) for social climate, mental health, and vitality, respectively. For social climate and vitality, this corresponded to moderate effect sizes (Cohen d = 0.51 for both) in favor of physical exercise. There were no reported adverse events. In conclusion, workplace physical exercise performed together with colleagues improves social climate and vitality among workers with chronic musculoskeletal pain. Mental health remained unchanged. PMID:28072707

Cost-effectiveness Evaluation of the Inclusion of Dry Needling into an Exercise Program for Subacromial Pain Syndrome: Evidence from a Randomized Clinical Trial.

PubMed

Arias-Buría, José L; Martín-Saborido, Carlos; Cleland, Joshua; Koppenhaver, Shane L; Plaza-Manzano, Gustavo; Fernández-de-Las-Peñas, César

2018-02-22

To evaluate the cost-effectiveness of the inclusion of trigger point-dry needling (TrP-DN) into an exercise program for the management of subacromial pain syndrome. Fifty patients with unilateral subacromial pain syndrome were randomized with concealed allocation to exercise alone or exercise plus TrP-DN. Both groups were asked to perform an exercise program targeting the rotator cuff musculature twice daily for five weeks. Patients allocated to the exercise plus TrP-DN group also received dry needling during the second and fourth sessions. Societal costs and health-related quality of life (estimated by EuroQol-5D-5L) over a one-year follow-up were used to generate incremental cost per quality-adjusted life-year (QALY) ratios for each intervention.  Intention-to-treat analysis was possible for 48 (96%) of the participants. Those in the exercise group made more visits to medical doctors and received a greater number of other treatments (P < 0.001). The major contributor to societal costs (77%) was the absenteeism paid labor in favor of the exercise plus TrP-DN group (P = 0.03). The combination of exercise plus TrP-DN was less costly (mean difference cost/patient = €517.34, P = 0.003) than exercise alone. Incremental QALYs showed greater benefit for exercise plus TrP-DN (difference = 2.87, 95% confidence interval = 2.85-2.89). Therefore, the inclusion of TrP-DN into an exercise program was more likely to be cost-effective than an exercise program alone, with 99.5% of the iterations falling in the dominant area. The inclusion of TrP-DN into an exercise program was more cost-effective for individuals with subacromial pain syndrome than exercise alone. From a cost-benefit perspective, the inclusion of TrP-DN into multimodal management of patients with subacromial pain syndrome should be considered.

Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial.

PubMed

Young, Sean D; Cumberland, William G; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

2013-09-03

Social networking technologies are an emerging tool for HIV prevention. To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Randomized, controlled trial with concealed allocation. (ClinicalTrials.gov: NCT01701206). Online. 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement were monitored. Participants could request a free, home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more than 93%. Only 2 Facebook communities were included for each group. Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. National Institute of Mental Health.

Using simulation pedagogy to teach clinical education skills: A randomized trial.

PubMed

Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

2016-05-01

Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

Effect of Risk of Bias on the Effect Size of Meta-Analytic Estimates in Randomized Controlled Trials in Periodontology and Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Wu, Yun-Chun; Scheidgen, Moritz; Tu, Yu-Kang

2015-01-01

Risk of bias (ROB) may threaten the internal validity of a clinical trial by distorting the magnitude of treatment effect estimates, although some conflicting information on this assumption exists. The objective of this study was evaluate the effect of ROB on the magnitude of treatment effect estimates in randomized controlled trials (RCTs) in periodontology and implant dentistry. A search for Cochrane systematic reviews (SRs), including meta-analyses of RCTs published in periodontology and implant dentistry fields, was performed in the Cochrane Library in September 2014. Random-effect meta-analyses were performed by grouping RCTs with different levels of ROBs in three domains (sequence generation, allocation concealment, and blinding of outcome assessment). To increase power and precision, only SRs with meta-analyses including at least 10 RCTs were included. Meta-regression was performed to investigate the association between ROB characteristics and the magnitudes of intervention effects in the meta-analyses. Of the 24 initially screened SRs, 21 SRs were excluded because they did not include at least 10 RCTs in the meta-analyses. Three SRs (two from periodontology field) generated information for conducting 27 meta-analyses. Meta-regression did not reveal significant differences in the relationship of the ROB level with the size of treatment effect estimates, although a trend for inflated estimates was observed in domains with unclear ROBs. In this sample of RCTs, high and (mainly) unclear risks of selection and detection biases did not seem to influence the size of treatment effect estimates, although several confounders might have influenced the strength of the association.

Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

PubMed

Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

2018-04-01

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Randomized clinical trial of transversus abdominis plane block versus placebo control in live-donor nephrectomy.

PubMed

Hosgood, Sarah A; Thiyagarajan, Umasanker M; Nicholson, Harriet F L; Jeyapalan, Inthira; Nicholson, Michael L

2012-09-15

Laparoscopic surgery reduces pain after donor nephrectomy; however, most patients still require a significant amount of postoperative parenteral opiate analgesia. Therefore, there is a need to investigate techniques that might further reduce postoperative pain. This study assessed the safety and efficacy of using a transversus abdominis plane (TAP) block in a randomized, double-blind, placebo-controlled trial. Forty-six patients were analyzed in the trial and were randomized to undergo the TAP block procedure with either bupivacaine (n=24) or saline placebo (Control n=22) injected into the muscle plane. Prefilled syringes were dispensed with the group allocation concealed to maintain blinding. After surgery, the amount of morphine, level of pain, and measures of recovery were recorded. The amount of morphine used 6 hr after surgery was significantly lower in patients receiving TAP block with bupivacaine compared with the control (presented as mean [SD], 12.4 [8.4] vs. 21.2 [14.0] mg; P=0.015). However, the total amount of morphine used was similar in both groups 45.6 [31.4] vs. 52.7 [28.8] mg; P=0.771. Patients in the bupivacaine group experienced significantly less pain on postoperative days 1 (score, 19 [15] vs. 37 [20]; P=0.003) and 2 (score, 11 [10] vs. 19 [13]; P=0.031). Recovery and postoperative hospital stay were similar in both groups. There were no complications associated with the procedure. The TAP block procedure is beneficial in reducing postoperative pain and early morphine requirements in laparoscopic live-donor nephrectomy.

Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

PubMed Central

2012-01-01

Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12612000909820) PMID:23110608

Comparison of patient acceptance of the Forsus Fatigue Resistant Device with and without mini-implant anchorage: a randomized controlled trial.

PubMed

Elkordy, Sherif A; Fayed, Mona M Salah; Abouelezz, Amr M; Attia, Khaled H

2015-11-01

The objective of this 2-arm parallel randomized controlled trial was to evaluate patient acceptance of the mini-implant anchored Forsus Fatigue Resistant Device (FFRD) (3M Unitek, Monrovia, Calif). The study included 32 skeletal Class II girls. The eligibility criteria included a deficient mandible, a horizontal or neutral growth pattern, an increased overjet, and a full set of erupted permanent teeth. After the leveling and alignment stage, FFRDs and mini-implants were inserted; they were removed after the teeth reached an edge-to-edge incisor relationship. The patients were afterward asked to fill out assessment questionnaires regarding their experience with the FFRD. The primary outcome of this study was to assess patient acceptance of the appliance and satisfaction with the results. The secondary outcomes were interference with functional activities, noticeability by others, pain, swelling, gum problems caused by the appliance, and appliance breakage. Computer random sequence generation was done using block sizes of 6 and 4. Allocation concealment was achieved with sequentially numbered opaque sealed envelopes. Blinding of the clinicians and the patients to the intervention was impossible, but it was done for the outcome assessment and the statistician. The 32 patients were randomly allocated in a 1:1 ratio into 2 groups: 16 patients (mean age, 13.25 ± 1.12 years) received the FFRD alone (FFRD group), and 16 patients (mean age, 13.07 ± 1.41 years) had mini-implants in conjunction with FFRDs (FMI group). No statistically significant differences were reported between the 2 groups regarding ease of appliance insertion, noticeability by others, pain, swelling, effects on eating and speech, and gum bleeding; 100% and 87.5% were satisfied with the results in the FFRD and FMI groups, respectively, with a ridit value of 0.57 (95% confidence interval, 0.43-0.71; P = 0.36). No serious harm was observed other than swelling of the cheeks, which occurred in 4 patients. There were no significant differences between the patients' acceptance of the FFRD and the mini-implant anchored FFRD. They were highly satisfied with the results. Neither group reported significant functional limitations. This trial was not registered. The protocol was not published before trial commencement. The study was self-funded by the authors. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.

PubMed

Vihstadt, Corrie; Maiers, Michele; Westrom, Kristine; Bronfort, Gert; Evans, Roni; Hartvigsen, Jan; Schulz, Craig

2014-01-01

Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability. The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability. Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area. Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200). 12 weeks SMT + SRE or 36 weeks SMT + SRE. Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes. Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment. 36 weeks post-randomization. Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected. Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates. Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy. www.ClinicalTrials.gov; Identifier: NCT01057706.

Balance circuit classes to improve balance among rehabilitation inpatients: a protocol for a randomised controlled trial.

PubMed

Treacy, Daniel; Schurr, Karl; Sherrington, Catherine

2013-07-20

Impaired balance and mobility are common among rehabilitation inpatients. Poor balance and mobility lead to an increased risk of falling. Specific balance exercise has been shown to improve balance and reduce falls within the community setting. However few studies have measured the effects of balance exercises on balance within the inpatient setting. A single centre, randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. One hundred and sixty two patients admitted to the general rehabilitation ward at Bankstown-Lidcombe Hospital will be recruited. Eligible participants will have no medical contraindications to exercise and will be able to: fully weight bear; stand unaided independently for at least 30 seconds; and participate in group therapy sessions with minimal supervision. Participants will be randomly allocated to an intervention group or usual-care control group. Both groups will receive standard rehabilitation intervention that includes physiotherapy mobility training and exercise for at least two hours on each week day. The intervention group will also receive six 1-hour circuit classes of supervised balance exercises designed to maximise the ability to make postural adjustments in standing, stepping and walking. The primary outcome is balance. Balance will be assessed by measuring the total time the participant can stand unsupported in five different positions; feet apart, feet together, semi-tandem, tandem and single-leg-stance. Secondary outcomes include mobility, self reported physical functioning, falls and hospital readmissions. Performance on the outcome measures will be assessed before randomisation and at two-weeks and three-months after randomisation by physiotherapists unaware of intervention group allocation. This study will determine the impact of additional balance circuit classes on balance among rehabilitation inpatients. The results will provide essential information to guide evidence-based physiotherapy at the study site as well as across other rehabilitation inpatient settings. The protocol for this study is registered with the Australian New Zealand, Clinical Trials Registry: ACTRN=12611000412932.

Training production of lexical stress in typically developing children using orthographically biased stimuli and principles of motor learning.

PubMed

van Rees, Lauren J; Ballard, Kirrie J; McCabe, Patricia; Macdonald-D'Silva, Anita G; Arciuli, Joanne

2012-08-01

Impaired lexical stress production characterizes multiple pediatric speech disorders. Effective remediation strategies are not available, and little is known about the normal process of learning to assign and produce lexical stress. This study examined whether typically developing (TD) children can be trained to produce lexical stress on bisyllabic pseudowords that are orthographically biased to a strong-weak or weak-strong pattern (e.g., MAMbey or beDOON), in combination with the principles of motor learning (PML). Fourteen TD children ages 5;0 (years;months) to 13;0 were randomly assigned to a training or control group using concealed allocation within blocks. A pre- to posttraining group design was used to examine the acquisition, retention, and generalization of lexical stress production. The training group learned to produce appropriate lexical stress for the pseudowords with strong maintenance and generalization to related untrained stimuli. Accuracy of stress production did not change in the control group. TD children can learn to produce lexical stress patterns for orthographically biased pseudowords via explicit training methods. Findings have relevance for the study of languages other than English and for a range of prosodic disorders.

The efficacy of chimeric antigen receptor (CAR) immunotherapy in animal models for solid tumors: A systematic review and meta-analysis.

PubMed

Wu, Yingcheng; Xu, Ran; Jia, Keren; Shi, Hui

2017-01-01

Most recently, an emerging theme in the field of tumor immunology predominates: chimeric antigen receptor (CAR) therapy in treating solid tumors. The number of related preclinical trials was surging. However, an evaluation of the effects of preclinical studies remained absent. Hence, a meta-analysis was conducted on the efficacy of CAR in animal models for solid tumors. The authors searched PubMed/Medline, Embase, and Google scholar up to April 2017. HR for survival was extracted based on the survival curve. The authors used fixed effect models to combine the results of all the trials. Heterogeneity was assessed by I-square statistic. Quality assessment was conducted following the Stroke Therapy Academic Industry Roundtable standard. Publication bias was assessed using Egger's test. Eleven trials were included, including 54 experiments with a total of 362 animals involved. CAR immunotherapy significantly improved the survival of animals (HR: 0.25, 95% CI: 0.13-0.37, P < 0.001). The quality assessment revealed that no study reported whether allocation concealment and blinded outcome assessment were conducted, and only five studies implemented randomization. This meta-analysis indicated that CAR therapy may be a potential clinical strategy in treating solid tumors.

Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups?

PubMed Central

2014-01-01

Background Studies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors. The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors. Methods We included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German. We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012. We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded. Results We included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding. None of the 205 journal publications provided sufficient details to assess allocation concealment, blinding of participants, caregivers and outcome assessors. After contacting authors for additional information, we judged five studies to be adequately (n = 1,202) and 16 to be inadequately (n = 3,006) blinded. The IIEF-EF score for placebo groups in adequately blinded trials versus inadequately blinded trials was 1.92 points (95% CI, 0.64 to 3.20) versus 1.56 (95% CI, 0.93 to 2.20), respectively. The IIEF-EF score for intervention groups in adequately blinded trials versus inadequately blinded trials was 9.40 (95% CI, 6.96 to 11.83) versus 8.33 (95% CI, 7.29 to 9.37), respectively. In a secondary analysis, prior experience with the drug affected the scores; in placebo groups with participants naïve to the intervention the score was 2.89 (95% CI, 2.33 to 3.45) versus -0.11 (95% CI, -2.06 to 1.84) with participants having prior experience. In the intervention groups, these scores were 7.99 (95% CI, 6.85 to 9.14) versus 8.33 (95% CI, 7.51 to 9.16), respectively. Unblinding lowered placebo scores (creating a nocebo effect) by 19% (0.33 points; 95% CI, -0.96 to 1.62). Unblinding lowered intervention scores by 11% (1.0; 95% CI, -1.35 to 3.47). The results provided no conclusive evidence for nocebo or enhanced placebo effects. Patients taking a PDE-5 inhibitor for the first time experience a larger placebo effect that accounts for 35% of the total effect. Conclusions Given the overall poor reporting of blinding in clinical trial reports and the small number of trials that could be rated as adequately or inadequately blinded, we could not draw any robust conclusions about the existence or absence of nocebo and enhanced placebo effects. A large placebo effect was found for patients taking PDE-5 inhibitors for the first time. It was not clear if previous exposure to the drug impacted trial blinding. We found clear evidence that studies assessing a subjective continuous outcome fail to report on measures taken to secure double blinding. Although we observed a trend for the presence of a nocebo effect, there was insufficient evidence to quantify its impact on expectations. RCTs with patients with no prior experience with PDE-5 inhibitors reported larger placebo effects and possibly these studies were better blinded. Future research should further investigate the factors that contribute to blinding and their impact on health outcomes in randomized trials of subjectively assessed conditions. This research is part of a PhD project and has no external funding. The authors have no competing interests to declare. PMID:24555576

Survival of bonded lingual retainers with chemical or photo polymerization over a 2-year period: a single-center, randomized controlled clinical trial.

PubMed

Pandis, Nikolaos; Fleming, Padhraig S; Kloukos, Dimitrios; Polychronopoulou, Argy; Katsaros, Christos; Eliades, Theodore

2013-08-01

The objective of this trial was to compare the survival rates of mandibular lingual retainers bonded with either chemically cured or light-cured adhesive after orthodontic treatment. Patients having undergone orthodontic treatment at a private orthodontic office were randomly allocated to fixed retainers placed with chemically cured composite or light-cured composite. Eligibility criteria included no active caries, restorations, or fractures on the mandibular anterior teeth, and adequate oral hygiene. The main outcome was any type of first-time lingual retainer breakage; pattern of failure (adapted adhesive remnant index scores) was a secondary outcome. Randomization was accomplished with random permuted blocks of 20 patients with allocation concealed in sequentially numbered, opaque, sealed envelopes. Blinding was applicable for outcome assessment only. Patients were reviewed at 1, 3, and 6 months and then every 6 months after placement of the retainer until completion of the study. Data were analyzed using survival analysis including Cox regression; sensitivity analysis was carried out after data imputation for subjects lost to follow-up. Two hundred twenty patients (median age, 16 years; interquartile range, 2; range, 12-47 years) were randomized in a 1:1 ratio to either chemical or light curing. Baseline characteristics were similar between groups, the median follow-up period was 2.19 years (range, 0.003-3.64 years), and 16 patients were lost to follow-up. At a minimum follow-up of 2 years, 47 of 110 (42.7%) and 55 of 110 (50.0%) retainers had some type of failure with chemically cured and light-cured adhesive, respectively (log-rank test, P = 0.35). Data were analyzed on an intention-to-treat basis, and the hazard ratio (HR) was 1.15 (95% confidence interval [CI], 0.88-1.70; P = 0.47). There was weak evidence that age is a significant predictor for lingual retainer failures (HR, 0.96; 95% CI, 0.93-1.00; P = 0.08). Adhesive remnant index scoring was possible for only 66 of the 102 (64.7%) failures and did not differ between composites (Fisher exact test, P = 0.16). No serious harm was observed other than gingivitis associated with plaque accumulation. The results of this study indicated no evidence that survival of mandibular lingual retainers differs between chemically and light-cured adhesives. The overall failure rate was 46.4%; however, this included any type of failure, which may have exaggerated the overall failure rate. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial.

PubMed

Glynn, Liam G; Hayes, Patrick S; Casey, Monica; Glynn, Fergus; Alvarez-Iglesias, Alberto; Newell, John; Ólaighin, Gearóid; Heaney, David; Murphy, Andrew W

2013-05-29

Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up.

Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms

PubMed Central

2014-01-01

Background Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability. The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability. Methods/Design Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area. Participants Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200). Interventions 12 weeks SMT + SRE or 36 weeks SMT + SRE. Randomization Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes. Blinding Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment. Primary endpoint 36 weeks post-randomization. Data collection Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected. Primary analysis Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates. Discussion Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy. Trial registry www.ClinicalTrials.gov; Identifier: NCT01057706. PMID:25478141

SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Sedentary lifestyles are now becoming a major concern for governments of developed and developing countries with physical inactivity related to increased all-cause mortality, lower quality of life, and increased risk of obesity, diabetes, hypertension and many other chronic diseases. The powerful onboard computing capacity of smartphones, along with the unique relationship individuals have with their mobile phones, suggests that mobile devices have the potential to influence behavior. However, no previous trials have been conducted using smartphone technology to promote physical activity. This project has the potential to provide robust evidence in this area of innovation. The aim of this study is to evaluate the effectiveness of a smartphone application as an intervention to promote physical activity in primary care. Methods/design A two-group, parallel randomized controlled trial (RCT) with a main outcome measure of mean difference in daily step count between baseline and follow up over eight weeks. A minimum of 80 active android smartphone users over 16 years of age who are able to undertake moderate physical activity are randomly assigned to the intervention group (n = 40) or to a control group (n = 40) for an eight week period. After randomization, all participants will complete a baseline period of one week during which a baseline mean daily step count will be established. The intervention group will be instructed in the usability features of the smartphone application, will be encouraged to try to achieve 10,000 steps per day as an exercise goal and will be given an exercise promotion leaflet. The control group will be encouraged to try to walk an additional 30 minutes per day along with their normal activity (the equivalent of 10,000 steps) as an exercise goal and will be given an exercise promotion leaflet. The primary outcome is mean difference in daily step count between baseline and follow-up. Secondary outcomes are systolic and diastolic blood pressure, resting heart rate, mental health score using HADS and quality of life score using Euroqol. Randomization and allocation to the intervention and groups will be carried out by an independent researcher, ensuring the allocation sequence is concealed from the study researchers until the interventions are assigned. The primary analysis is based on mean daily step count, comparing the mean difference in daily step count between the baseline and the trial periods in the intervention and control groups at follow up. Trial registration Current Controlled Trials ISRCTN99944116 PMID:23714362

Indirect vs direct bonding of mandibular fixed retainers in orthodontic patients: a single-center randomized controlled trial comparing placement time and failure over a 6-month period.

PubMed

Bovali, Efstathia; Kiliaridis, Stavros; Cornelis, Marie A

2014-12-01

The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure. Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure. Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4; the randomization sequence was generated using an online randomization service (www.randomization.com). Allocation concealment was secured by contacting the sequence generator for treatment assignment; blinding was possible for outcome assessment only. Bonding time was measured for each procedure. Unpaired t tests were used to assess differences in time. Patients were recalled at 1, 2, 4, and 6 months after bonding. Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures. The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures. A test of proportion was applied to compare the failures at 6 months between the treatment groups. Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline after the bonding procedure, and 3 patients did not attend the recalls at 4 and 6 months. Bonding time was significantly shorter for the indirect procedure (321 ± 31 seconds, mean ± SD) than for the direct procedure (401 ± 40 seconds) (per protocol analysis of 63 patients: mean difference = 80 seconds; 95% CI = 62.4-98.1; P <0.001). The 6-month numbers of failures were 10 of 31 (32%) with the indirect technique and 7 of 29 (24%) with the direct technique (log rank: P = 0.35; test of proportions: risk difference = 0.08; 95% CI = -0.15 to 0.31; P = 0.49). No serious harm was observed except for plaque accumulation. Indirect bonding was statistically significantly faster than direct bonding, with both techniques showing similar risks of failure. This trial was not registered. The protocol was not published before trial commencement. No funding or conflict of interest to be declared. Copyright © 2014 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

The dominance of big pharma: power.

PubMed

Edgar, Andrew

2013-05-01

The purpose of this paper is to provide a normative model for the assessment of the exercise of power by Big Pharma. By drawing on the work of Steven Lukes, it will be argued that while Big Pharma is overtly highly regulated, so that its power is indeed restricted in the interests of patients and the general public, the industry is still able to exercise what Lukes describes as a third dimension of power. This entails concealing the conflicts of interest and grievances that Big Pharma may have with the health care system, physicians and patients, crucially through rhetorical engagements with Patient Advocacy Groups that seek to shape public opinion, and also by marginalising certain groups, excluding them from debates over health care resource allocation. Three issues will be examined: the construction of a conception of the patient as expert patient or consumer; the phenomenon of disease mongering; the suppression or distortion of debates over resource allocation.

A Systematic Review of Information and Communication Technology–Based Interventions for Promoting Physical Activity Behavior Change in Children and Adolescents

PubMed Central

Lau, Erica Y; Wong, Del P; Ransdell, Lynda

2011-01-01

Background A growing body of research has employed information and communication technologies (ICTs) such as the Internet and mobile phones for disseminating physical activity (PA) interventions with young populations. Although several systematic reviews have documented the effects of ICT-based interventions on PA behavior, very few have focused on children and adolescents specifically. Objectives The present review aimed to systematically evaluate the efficacy and methodological quality of ICT-based PA interventions for children and adolescents based on evidence from randomized controlled trials. Methods Electronic databases Medline, PsycInfo, CINAHL, and Web of Science were searched to retrieve English language articles published in international academic peer-reviewed journals from January 1, 1997, through December 31, 2009. Included were articles that provided descriptions of interventions designed to improve PA-related cognitive, psychosocial, and behavioral outcomes and that used randomized controlled trial design, included only children (6-12 years old) and adolescents (13-18 years old) in both intervention and control groups, and employed Internet, email, and/or short message services (SMS, also known as text messaging) as one or more major or assistive modes to deliver the intervention. Results In total, 9 studies were analyzed in the present review. All studies were published after 2000 and conducted in Western countries. Of the 9 studies, 7 demonstrated positive and significant within-group differences in at least one psychosocial or behavioral PA outcome. In all, 3 studies reported positive and significant between-group differences favoring the ICT group. When between-group differences were compared across studies, effect sizes were small in 6 studies and large in 3 studies. With respect to methodological quality, 7 of the 9 studies had good methodological quality. Failure to report allocation concealment, blinding to outcome assessment, and lack of long-term follow-up were the criteria met by the fewest studies. In addition, 5 studies measured the intervention exposure rate and only 1 study employed objective measures to record data. Conclusion The present review provides evidence supporting the positive effects of ICTs in PA interventions for children and adolescents, especially when used with other delivery approaches (ie, face-to-face). Because ICT delivery approaches are often mixed with other approaches and these studies sometimes lack a comparable control group, additional research is needed to establish the true independent effects of ICT as an intervention delivery mode. Although two-thirds of the studies demonstrated satisfactory methodological quality, several quality criteria should be considered in future studies: clear descriptions of allocation concealment and blinding of outcome assessment, extension of intervention duration, and employment of objective measures in intervention exposure rate. Due to the small number of studies that met inclusion criteria and the lack of consistent evidence, researchers should be cautious when interpreting the findings of the present review. PMID:21749967

A systematic review of information and communication technology-based interventions for promoting physical activity behavior change in children and adolescents.

PubMed

Lau, Patrick W C; Lau, Erica Y; Wong, Del P; Ransdell, Lynda

2011-07-13

A growing body of research has employed information and communication technologies (ICTs) such as the Internet and mobile phones for disseminating physical activity (PA) interventions with young populations. Although several systematic reviews have documented the effects of ICT-based interventions on PA behavior, very few have focused on children and adolescents specifically. The present review aimed to systematically evaluate the efficacy and methodological quality of ICT-based PA interventions for children and adolescents based on evidence from randomized controlled trials. Electronic databases Medline, PsycInfo, CINAHL, and Web of Science were searched to retrieve English language articles published in international academic peer-reviewed journals from January 1, 1997, through December 31, 2009. Included were articles that provided descriptions of interventions designed to improve PA-related cognitive, psychosocial, and behavioral outcomes and that used randomized controlled trial design, included only children (6-12 years old) and adolescents (13-18 years old) in both intervention and control groups, and employed Internet, email, and/or short message services (SMS, also known as text messaging) as one or more major or assistive modes to deliver the intervention. In total, 9 studies were analyzed in the present review. All studies were published after 2000 and conducted in Western countries. Of the 9 studies, 7 demonstrated positive and significant within-group differences in at least one psychosocial or behavioral PA outcome. In all, 3 studies reported positive and significant between-group differences favoring the ICT group. When between-group differences were compared across studies, effect sizes were small in 6 studies and large in 3 studies. With respect to methodological quality, 7 of the 9 studies had good methodological quality. Failure to report allocation concealment, blinding to outcome assessment, and lack of long-term follow-up were the criteria met by the fewest studies. In addition, 5 studies measured the intervention exposure rate and only 1 study employed objective measures to record data. The present review provides evidence supporting the positive effects of ICTs in PA interventions for children and adolescents, especially when used with other delivery approaches (ie, face-to-face). Because ICT delivery approaches are often mixed with other approaches and these studies sometimes lack a comparable control group, additional research is needed to establish the true independent effects of ICT as an intervention delivery mode. Although two-thirds of the studies demonstrated satisfactory methodological quality, several quality criteria should be considered in future studies: clear descriptions of allocation concealment and blinding of outcome assessment, extension of intervention duration, and employment of objective measures in intervention exposure rate. Due to the small number of studies that met inclusion criteria and the lack of consistent evidence, researchers should be cautious when interpreting the findings of the present review.

Does depression treatment improve the survival of depressed patients with cancer? A long-term follow-up of participants in the SMaRT Oncology-2 and 3 trials.

PubMed

Mulick, Amy; Walker, Jane; Puntis, Stephen; Burke, Katy; Symeonides, Stefan; Gourley, Charlie; Wanat, Marta; Frost, Chris; Sharpe, Michael

2018-04-01

Comorbid major depression has been associated with worse survival in patients with cancer. However, we do not know if treating depression improves survival. In the SMaRT Oncology-2 (good prognosis cancers) and SMaRT Oncology-3 (lung cancer, a poor prognosis cancer) trials, we found that a depression treatment programme, Depression Care for People with Cancer (DCPC), was effective in reducing comorbid major depression. In this analysis, we aimed to identify whether DCPC also had an effect on survival. The trials were conducted in three cancer centres and their associated clinics in Scotland, UK. In SMaRT Oncology-2, outpatients with good prognosis cancers and major depression were randomly assigned in a 1:1 ratio to DCPC or usual care, with stratification (by trial centre) and minimisation (by age, primary cancer, and sex) with allocation concealment. In SMaRT Oncology-3, outpatients with lung cancer and major depression were randomly assigned (1:1 ratio) to DCPC or usual care with stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. For this analysis, we obtained long-term data on deaths (all causes) in the SMaRT Oncology-2 and 3 trial participants, censored at July 31, 2015, and analysed survival as a trial outcome. We estimated unadjusted hazard ratios (HRs) for each trial using Cox regression, and pooled the log HRs in a fixed-effects meta-analysis. We recruited 642 participants; between May 12, 2008, and May 13, 2011, 500 participants were recruited to the SMaRT Oncology-2 trial and between Jan 5, 2009, and Sept 9, 2011, 142 participants were recruited to the SMaRT Oncology-3 trial. We followed up SMaRT Oncology-2 and SMaRT Oncology-3 participants for a median of 5 years and 1 year, respectively. 135 (27%) of 500 SMaRT Oncology-2 participants and 114 (80%) of 142 SMaRT Oncology-3 participants died within this period. We found no significant effect of DCPC on survival in the total follow-up period for either SMaRT Oncology 2 (HR 1·02, 95% CI 0·72-1·42, p=0·93) or SMaRT Oncology-3 (HR 0·82, 95% CI 0·56-1·18, p=0·28; pooled HR 0·92, 95% CI 0·72-1·18, p=0·51). DCPC is highly effective in improving depression and quality of life in depressed patients with cancer, but there was no evidence for a significant effect on survival. Despite the absence of an effect on length of life, the management of depression remains important for its beneficial effect on quality of life. NIHR CLAHRC Oxford, Cancer Research UK, and the Chief Scientist Office of the Scottish Government. Copyright © 2018 Elsevier Ltd. All rights reserved.

Oncology trial abstracts showed suboptimal improvement in reporting: a comparative before-and-after evaluation using CONSORT for Abstract guidelines.

PubMed

Ghimire, Saurav; Kyung, Eunjung; Lee, Heeyoung; Kim, Eunyoung

2014-06-01

The aims of this study were to evaluate the quality of randomized controlled trial (RCT) abstracts published in the field of oncology and identify characteristics associated with better reporting quality. All phase III trials published during 2005-2007 [before Consolidated Standards of Reporting Trials (CONSORT)] and 2010-2012 (after CONSORT) were searched electronically in MEDLINE/PubMed and retrieved for review using an 18-point overall quality score (OQS) for reporting based on the CONSORT for Abstract guidelines. Descriptive statistics followed by multivariate linear regression were used to identify features associated with improved reporting quality. The mean OQS was 8.2 (range: 5-13; 95% confidence interval (CI): 8.0, 8.3) and 9.9 (range: 5-18; 95% CI: 9.7, 10.2) in the pre- and post-CONSORT periods, respectively. The method for random sequence generation, allocation concealment, blinding details, and funding sources were missing in pre-CONSORT abstracts and insufficiently reported (<20%) in post-CONSORT abstracts. A high impact factor (P < 0.001) and the journal of publication (P < 0.001) were independent factors that were significantly associated with higher reporting quality on multivariate analysis. The reporting quality of RCT abstracts in oncology showed suboptimal improvement over time. Thus, stricter adherence to the CONSORT for Abstract guidelines is needed to improve the reporting quality of RCT abstracts published in oncology. Copyright © 2014 Elsevier Inc. All rights reserved.

Botulinum toxin A injections and occupational therapy in children with unilateral spastic cerebral palsy: a randomized controlled trial.

PubMed

Lidman, Git; Nachemson, Ann; Peny-Dahlstrand, Marie; Himmelmann, Kate

2015-08-01

To investigate the effects of repeated botulinum toxin A (BoNT-A) injections combined with occupational therapy, including a splint, compared with occupational therapy alone on hand function in children with unilateral spastic cerebral palsy (USCP), in all International Classification of Functioning, Disability and Health (ICF) domains. This was a randomized controlled study, population-based and evaluator-blinded for primary outcome (October 2004 to September 2010). Twenty children (14 males; median age 3y 1mo) with USCP, recruited at a rehabilitation centre in Sweden, were assigned to one of two parallel groups using concealed allocation. In the course of one year, 10 children received occupational therapy, while 10 received repeated BoNT-A plus occupational therapy (BoNT-A/OT). Primary outcome (Assisting Hand Assessment [AHA]), and secondary outcome measures (range of movement [ROM], and Canadian Occupational Performance Measure), were measured at baseline, 3, 6, 9, and 12 months. AHA revealed a superior effect in the BoNT-A/OT group at 12 months: 6 out of 10 improved compared with 1 out of 10 in the occupational therapy group (p<0.03). A 95% Peskun exact confidence interval for the difference in proportions is given as 0.01 to 0.81. Secondary outcomes improved in both groups. Repeated BoNT-A/OT appeared superior to occupational therapy alone for bimanual performance in young children with USCP. Active ROM and goal performance improved in both groups. © 2015 Mac Keith Press.

Does the reporting of randomized clinical trials published in Chinese pediatrics journals improve after the CONSORT Statement is adopted?

PubMed

Ma, Bin; Ke, Fa-yong; Chen, Zhi-min; Qi, Guo-qing; Li, Hai-min; Liu, Wen-jie; Zhang, Yuan; Hu, Qing; Yang, Ke-hu

2012-09-01

There is no systematic assessment whether the quality of reporting has been improved since the CONSORT Statement was introduced into China in 1997. The aim of this study is to determine whether the use of the CONSORT Statement is associated with improved quality of reporting of RCTs published in Chinese pediatrics journals. Six core Chinese pediatrics journals that included Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, and Chinese Journal of Pediatric Surgery were searched from inception through Dec. 2010. The CONSORT checklists were used to assess the quality of reporting. Data was collected using a standardized form. Analyses were performed using SPSS 15.0 software. A total of 619 RCTs were included. The quality of reporting has improved significantly in aspects such as introduction, recruitment, baseline data, and ancillary analyses (p<0.05), but not in several important methodological components, including sample size calculation (0.63% vs.1.08%), randomization sequence generation (3.18% vs. 7.58%), allocation concealment (0% vs. 1.08%), and blinding (0% vs. 0.87%). The quality of reporting of RCTs has not significantly improved since the CONSORT Statement was introduced into China. The reporting remains poor, and often inadequate for assessment of the rigor of studies. Chinese pediatrics journals should reinforce the use of the CONSORT Statement in the reporting of trials. Copyright © 2012 Elsevier Inc. All rights reserved.

Biochemical tests of placental function for assessment in pregnancy.

PubMed

Neilson, James P

2012-08-15

Biochemical tests of placental or feto-placental function were widely used in the 1960s and 1970s in high-risk pregnancies to try to predict, and thus try to avoid, adverse fetal outcome. To assess the effects of performing biochemical tests of placental function in high-risk, low-risk, or unselected pregnancies. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (10 May 2012). Controlled trials (randomized or 'quasi-randomized') that compare the use of biochemical tests of placental function in pregnancy with non-use. Trial quality was assessed and data were extracted by the review author. A single eligible trial of poor quality was identified. It involved 622 women with high-risk pregnancies who had had plasma (o)estriol estimations. Women were allocated to have their (o)estriol results revealed or concealed on the basis of hospital record number (with attendant risk of selection bias). There were no obvious differences in perinatal mortality (relative risk (RR) 0.88, 95% confidence interval (CI) 0.36 to 2.13) or planned delivery (RR 0.97, 95% CI 0.81 to 1.15) between the two groups. The available trial data do not support the use of (o)estriol estimation in high-risk pregnancies. The single small trial available does not have the power to exclude a beneficial effect but this is probably of historical interest since biochemical testing has been superseded by biophysical testing in antepartum fetal assessment.

Reporting outcomes of definitive radiation-based treatment for esophageal cancer: a review of the literature.

PubMed

Main, B G; Strong, S; McNair, A G; Falk, S J; Crosby, T; Blazeby, J M

2015-01-01

Accurate evaluation of radical radiotherapy requires well designed research with valid and appropriate outcomes. This study reviewed standards of outcome reporting and study design in randomized controlled trials (RCTs) of radiation-based therapy for esophageal cancer and made recommendations for future work. Randomized controlled trials reporting outcomes of definitive radiation-based treatment alone or in combination with chemotherapy were systematically identified and summarized. The types, frequency, and definitions of all clinical and patient-reported outcomes (PROs) reported in the methods and results sections of papers were examined. Studies providing a definition for at least one outcome and presenting all outcomes reported in the methods were classified as high quality. From 1425 abstracts, 16 RCTs including 1803 patients were identified. The primary outcome was overall survival in 13 studies, but five different definitions were reported. Outcomes for treatment failure included local, regional, and distant failures, and inconsistent definitions were applied. An observer assessment of dysphagia was reported in seven RCTs but PROs were reported in only one. Only three RCTs were at low risk of bias, with all lacking reports of sequence generation and only a minority reporting allocation concealment. The quality of outcome reporting in RCTs was inconsistent and risked bias. A core outcome set including clinical and PROs is needed to improve reporting of trials of definitive radiation-based treatment for esophageal cancer. © 2014 International Society for Diseases of the Esophagus.

Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?

PubMed

Als-Nielsen, Bodil; Chen, Wendong; Gluud, Christian; Kjaergard, Lise L

2003-08-20

Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions. To explore whether the association between funding and conclusions in randomized drug trials reflects treatment effects or adverse events. Observational study of 370 randomized drug trials included in meta-analyses from Cochrane reviews selected from the Cochrane Library, May 2001. From a random sample of 167 Cochrane reviews, 25 contained eligible meta-analyses (assessed a binary outcome; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment). The primary binary outcome from each meta-analysis was considered the primary outcome for all trials included in each meta-analysis. The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect, adverse events, and additional confounding factors (methodological quality, control intervention, sample size, publication year, and place of publication). Conclusions in trials, classified into whether the experimental drug was recommended as the treatment of choice or not. The experimental drug was recommended as treatment of choice in 16% of trials funded by nonprofit organizations, 30% of trials not reporting funding, 35% of trials funded by both nonprofit and for-profit organizations, and 51% of trials funded by for-profit organizations (P<.001; chi2 test). Logistic regression analyses indicated that funding, treatment effect, and double blinding were the only significant predictors of conclusions. Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice (odds ratio, 5.3; 95% confidence interval, 2.0-14.4) compared with trials funded by nonprofit organizations. This association did not appear to reflect treatment effect or adverse events. Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results. Readers should carefully evaluate whether conclusions in randomized trials are supported by data.

Acceptability and performance of the menstrual cup in South Africa: a randomized crossover trial comparing the menstrual cup to tampons or sanitary pads.

PubMed

Beksinska, Mags E; Smit, Jenni; Greener, Ross; Todd, Catherine S; Lee, Mei-ling Ting; Maphumulo, Virginia; Hoffmann, Vivian

2015-02-01

In low-income settings, many women and girls face activity restrictions during menses, owing to lack of affordable menstrual products. The menstrual cup (MC) is a nonabsorbent reusable cup that collects menstrual blood. We assessed the acceptability and performance of the MPower® MC compared to pads or tampons among women in a low-resource setting. We conducted a randomized two-period crossover trial at one site in Durban, South Africa, between January and November 2013. Participants aged 18-45 years with regular menstrual cycles were eligible for inclusion if they had no intention of becoming pregnant, were using an effective contraceptive method, had water from the municipal system as their primary water source, and had no sexually transmitted infections. We used a computer-generated randomization sequence to assign participants to one of two sequences of menstrual product use, with allocation concealed only from the study investigators. Participants used each method over three menstrual cycles (total 6 months) and were interviewed at baseline and monthly follow-up visits. The product acceptability outcome compared product satisfaction question scores using an ordinal logistic regression model with individual random effects. This study is registered on the South African Clinical Trials database: number DOH-27-01134273. Of 124 women assessed, 110 were eligible and randomly assigned to selected menstrual products. One hundred and five women completed all follow-up visits. By comparison to pads/tampons (usual product used), the MC was rated significantly better for comfort, quality, menstrual blood collection, appearance, and preference. Both of these comparative outcome measures, along with likelihood of continued use, recommending the product, and future purchase, increased for the MC over time. MC acceptance in a population of novice users, many with limited experience with tampons, indicates that there is a pool of potential users in low-resource settings.

Internet-Based Assessment of Oncology Health Care Professional Learning Style and Optimization of Materials for Web-Based Learning: Controlled Trial With Concealed Allocation.

PubMed

Micheel, Christine M; Anderson, Ingrid A; Lee, Patricia; Chen, Sheau-Chiann; Justiss, Katy; Giuse, Nunzia B; Ye, Fei; Kusnoor, Sheila V; Levy, Mia A

2017-07-25

Precision medicine has resulted in increasing complexity in the treatment of cancer. Web-based educational materials can help address the needs of oncology health care professionals seeking to understand up-to-date treatment strategies. This study aimed to assess learning styles of oncology health care professionals and to determine whether learning style-tailored educational materials lead to enhanced learning. In all, 21,465 oncology health care professionals were invited by email to participate in the fully automated, parallel group study. Enrollment and follow-up occurred between July 13 and September 7, 2015. Self-enrolled participants took a learning style survey and were assigned to the intervention or control arm using concealed alternating allocation. Participants in the intervention group viewed educational materials consistent with their preferences for learning (reading, listening, and/or watching); participants in the control group viewed educational materials typical of the My Cancer Genome website. Educational materials covered the topic of treatment of metastatic estrogen receptor-positive (ER+) breast cancer using cyclin-dependent kinases 4/6 (CDK4/6) inhibitors. Participant knowledge was assessed immediately before (pretest), immediately after (posttest), and 2 weeks after (follow-up test) review of the educational materials. Study statisticians were blinded to group assignment. A total of 751 participants enrolled in the study. Of these, 367 (48.9%) were allocated to the intervention arm and 384 (51.1%) were allocated to the control arm. Of those allocated to the intervention arm, 256 (69.8%) completed all assessments. Of those allocated to the control arm, 296 (77.1%) completed all assessments. An additional 12 participants were deemed ineligible and one withdrew. Of the 552 participants, 438 (79.3%) self-identified as multimodal learners. The intervention arm showed greater improvement in posttest score compared to the control group (0.4 points or 4.0% more improvement on average; P=.004) and a higher follow-up test score than the control group (0.3 points or 3.3% more improvement on average; P=.02). Although the study demonstrated more learning with learning style-tailored educational materials, the magnitude of increased learning and the largely multimodal learning styles preferred by the study participants lead us to conclude that future content-creation efforts should focus on multimodal educational materials rather than learning style-tailored content. ©Christine M Micheel, Ingrid A Anderson, Patricia Lee, Sheau-Chiann Chen, Katy Justiss, Nunzia B Giuse, Fei Ye, Sheila V Kusnoor, Mia A Levy. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 25.07.2017.

Microhabitat characteristics of Lapland Longspur, Calcarius lapponicus, nests at Cape Churchill, Manitoba

USGS Publications Warehouse

Boal, C.W.; Andersen, D.E.

2005-01-01

We examined microsite characteristics at 21 Lapland Longspur (Calcarius lapponicus) nests and land cover types in which they occurred in Wapusk National Park, Cape Churchill, Manitoba. Nests were located in four of six physiographic-vegetation land-cover types. Regardless of land-cover type, all but one nest was built on a pressure ridge or mound. Nests were built midway between the bottom and top of ridges or mounds with steeper slopes than was randomly available. Longspur nests had a distinctive southwest orientation (P < 0.001). Longspurs selected nest sites that consisted of comparatively greater amounts of shrub species and lesser amounts of moss than were randomly available. Nests were generally well concealed by vegetation (mean = 67.0%) and concealment was negatively associated with amount of graminoid species at the nest (P = 0.0005). Our nesting habitat data may facilitate a better understanding of breeding Lapland Longspur habitat requirements, and potential impacts of habitat degradation by increasing Snow Goose (Chen caerulescens) populations in the study area.

Brick tunnel randomization and the momentum of the probability mass.

PubMed

Kuznetsova, Olga M

2015-12-30

The allocation space of an unequal-allocation permuted block randomization can be quite wide. The development of unequal-allocation procedures with a narrower allocation space, however, is complicated by the need to preserve the unconditional allocation ratio at every step (the allocation ratio preserving (ARP) property). When the allocation paths are depicted on the K-dimensional unitary grid, where allocation to the l-th treatment is represented by a step along the l-th axis, l = 1 to K, the ARP property can be expressed in terms of the center of the probability mass after i allocations. Specifically, for an ARP allocation procedure that randomizes subjects to K treatment groups in w1 :⋯:wK ratio, w1 +⋯+wK =1, the coordinates of the center of the mass are (w1 i,…,wK i). In this paper, the momentum with respect to the center of the probability mass (expected imbalance in treatment assignments) is used to compare ARP procedures in how closely they approximate the target allocation ratio. It is shown that the two-arm and three-arm brick tunnel randomizations (BTR) are the ARP allocation procedures with the tightest allocation space among all allocation procedures with the same allocation ratio; the two-arm BTR is the minimum-momentum two-arm ARP allocation procedure. Resident probabilities of two-arm and three-arm BTR are analytically derived from the coordinates of the center of the probability mass; the existence of the respective transition probabilities is proven. Probability of deterministic assignments with BTR is found generally acceptable. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol

PubMed Central

Figueras, Francesc; Gratacos, Eduard; Rial, Marta; Gull, Ilan; Krofta, Ladislav; Lubusky, Marek; Rogelio, Cruz-Martinez; Mónica, Cruz-Lemini; Miguel, Martinez-Rodriguez; Socias, Pamela; Aleuanlli, Cristina; Cordero, Mauro C Parra

2017-01-01

Introduction Fetal growth restriction (FGR) affects 5%–10% of all pregnancies, contributing to 30%–50% of stillbirths. Unfortunately, growth restriction often is not detected antenatally. The last weeks of pregnancy are critical for preventing stillbirth among babies with FGR because there is a pronounced increase in stillbirths among growth-restricted fetuses after 37 weeks of pregnancy. Here we present a protocol (V.1, 23 May 2016) for the RATIO37 trial, which evaluates an integrated strategy for accurately selecting at-risk fetuses for delivery at term. The protocol is based on the combination of fetal biometry and cerebroplacental ratio (CPR). The primary objective is to reduce stillbirth rates. The secondary aims are to detect low birth weights and adverse perinatal outcomes. Methods and analysis The study is designed as multicentre (Spain, Chile, Mexico,Czech Republic and Israel), open-label, randomised trial with parallel groups. Singleton pregnancies will be invited to participate after routine second-trimester ultrasound scan (19+0–22+6 weeks of gestation), and participants will be randomly allocated to receive revealed or concealed CPR evaluation. Then, a routine ultrasound and Doppler scan will be performed at 36+0–37+6 weeks. Sociodemographic and clinical data will be collected at enrolment. Ultrasound and Doppler variables will be recorded at 36+0–37+6 weeks of pregnancy. Perinatal outcomes will be recorded after delivery. Univariate (with estimated effect size and its 95% CI) and multivariate (mixed-effects logistic regression) comparisons between groups will be performed. Ethics and dissemination The study will be conducted in accordance with the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 23May 2016. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences. Trial registration number NCT02907242; pre-results. PMID:28619771

Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204

PubMed Central

Cyna, Allan M; Andrew, Marion I; Robinson, Jeffrey S; Crowther, Caroline A; Baghurst, Peter; Turnbull, Deborah; Wicks, Graham; Whittle, Celia

2006-01-01

Background Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Methods/design A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and < 39 weeks gestation, planning a vaginal birth, not in active labour, with a singleton, viable fetus of vertex presentation, are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups commence hypnosis training as near as possible to 37 weeks gestation. Treatment allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women/group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia – the primary endpoint. We estimate that approximately 5–10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women/group and perform sequential interim analyses when 150 and 300 participants have been recruited. All participant data will be analysed, by a researcher blinded to treatment allocation, according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses. Discussion If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice. PMID:16515709

Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

PubMed Central

2013-01-01

Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD) is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs) involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well-designed RCTs are needed. PMID:23336848

Effects of Mind-Body Exercises for Mood and Functional Capabilities in Patients with Stroke: An Analytical Review of Randomized Controlled Trials.

PubMed

Zou, Liye; Yeung, Albert; Zeng, Nan; Wang, Chaoyi; Sun, Li; Thomas, Garrett Anthony; Wang, Huiru

2018-04-11

Objective : The effects of stroke are both physical and mental in nature and may have serious implications on the overall well-being of stroke survivors. This analytical review aims to critically evaluate and statistically synthesize the existing literature regarding the effects of mind-body (MB) exercises on mood and functional capabilities in patients with stroke. Methods : A structured literature review was performed in both English (PubMed, PEDro, and Cochrane Library) and Chinese (Wanfang and CNKI (Chinese National Knowledge Information Database)) databases. Sixteen randomized controlled trials were considered eligible for meta-analysis. Based on the random effects model, we used the pooled effect size to determine the magnitude of rehabilitative effect of MB exercise intervention on depression, anxiety, activities of daily living, and functional mobility among stroke survivors. The sum PEDro score ranged from five to nine points (fair-to-good methodological quality), but the absence of concealed allocation and blinded assessors were reported in most studies. Results : The aggregated results showed that MB exercise intervention is associated with significantly improved ADL (Hedges' g = 1.31, 95% CI 0.85 to 1.77, p < 0.001, I ² = 79.82%) and mobility (Hedges' g = 0.67, 95% CI 0.25 to 1.09, p < 0.001, I ² = 69.65%), and reduced depression (Hedges' g = -0.76, 95% CI -1.16 to -0.35, p < 0.001, I ² = 74.84%). Conclusions : as add-on treatments, the MB exercises may potentially improve depression, activities of daily living, and mobility of these post-stroke patients. Future studies with more robust methodology will be needed to provide a more definitive conclusion.

Improving anxiety regulation in patients with breast cancer at the beginning of the survivorship period: a randomized clinical trial comparing the benefits of single-component and multiple-component group interventions.

PubMed

Merckaert, Isabelle; Lewis, Florence; Delevallez, France; Herman, Sophie; Caillier, Marie; Delvaux, Nicole; Libert, Yves; Liénard, Aurore; Nogaret, Jean-Marie; Ogez, David; Scalliet, Pierre; Slachmuylder, Jean-Louis; Van Houtte, Paul; Razavi, Darius

2017-08-01

To compare in a multicenter randomized controlled trial the benefits in terms of anxiety regulation of a 15-session single-component group intervention (SGI) based on support with those of a 15-session multiple-component structured manualized group intervention (MGI) combining support with cognitive-behavioral and hypnosis components. Patients with nonmetastatic breast cancer were randomly assigned at the beginning of the survivorship period to the SGI (n = 83) or MGI (n = 87). Anxiety regulation was assessed, before and after group interventions, through an anxiety regulation task designed to assess their ability to regulate anxiety psychologically (anxiety levels) and physiologically (heart rates). Questionnaires were used to assess psychological distress, everyday anxiety regulation, and fear of recurrence. Group allocation was computer generated and concealed till baseline completion. Compared with patients in the SGI group (n = 77), patients attending the MGI group (n = 82) showed significantly reduced anxiety after a self-relaxation exercise (P = .006) and after exposure to anxiety triggers (P = .013) and reduced heart rates at different time points throughout the task (P = .001 to P = .047). The MGI participants also reported better everyday anxiety regulation (P = .005), greater use of fear of recurrence-related coping strategies (P = .022), and greater reduction in fear of recurrence-related psychological distress (P = .017) compared with the SGI group. This study shows that an MGI combining support with cognitive-behavioral techniques and hypnosis is more effective than an SGI based only on support in improving anxiety regulation in patients with breast cancer. Copyright © 2016 John Wiley & Sons, Ltd.

Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial.

PubMed

Arguisuelas, María D; Lisón, Juan Francisco; Sánchez-Zuriaga, Daniel; Martínez-Hurtado, Isabel; Doménech-Fernández, Julio

2017-05-01

Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate myofascial release (MFR) protocol on pain, disability, and fear-avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty-four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain Questionnaire (SF-MPQ) and visual analog scale (VAS), disability measured with Roland Morris Questionnaire, and fear-avoidance beliefs measured with Fear-Avoidance Beliefs Questionnaire. Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% confidence interval [CI]: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the Fear-Avoidance Beliefs Questionnaire score also displayed a significant decrease in the MFR group (P < 0.05) as compared to sham MFR. MFR therapy produced a significant improvement in both pain and disability. Because the minimal clinically important differences in pain and disability are, however, included in the 95% CI, we cannot know whether this improvement is clinically relevant. 2.

Social networking technologies as emerging tools for HIV prevention: A Cluster Randomized Trial

PubMed Central

Young, Sean D.; Cumberland, William G.; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

2013-01-01

Background Social networking technologies are an emerging tool for HIV prevention. Objective To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Design Randomized; controlled trial with concealed allocation (ClinicalTrials.gov: NCT01701206). Setting Online. Patients 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Intervention Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement was monitored. Participants could request a free home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Measurements Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Results Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of the 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more 93%. Limitations Only 2 Facebook communities were included for each group. Conclusions Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. Primary funding source National Institute of Mental Health ClinicalTrials.gov Identifier (NCT01701206) PMID:24026317

A quality assessment of randomized controlled trial reports in endodontics.

PubMed

Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

2017-03-01

To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Manual Therapy With Cryotherapy Versus Manual Therapy With Kinesio Taping for Males With Lumbar Discopathy: A Pilot Randomized Trial.

PubMed

Lizis, Pawel; Kobza, Wojciech

2017-06-23

Context • Numerous modalities of therapeutic interventions exist for lumbar discopathy. Manual therapy is one option, although its effectiveness remains controversial. The addition of cryotherapy to manual therapy may enhance the health benefits in patients with lumbar discopathy.  Objective • The study intended to evaluate the efficacy of manual therapy combined with cryotherapy vs manual therapy combined with Kinesio taping for males with lumbar discopathy. Design • The research team designed a pilot randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting • The study occurred in the Physiotherapy Outpatient Department of the Regional Hospital (Zywiec, Poland). Participants • The participants were 40 males with lumbar discopathy, aged 30-75 y, who were patients in the department at the hospital. Intervention • The participants were randomly assigned to an intervention group that received Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) combined with cryotherapy, the KEOMT-C group (n = 20), or to a control group that received KEOMT combined with Kinesio taping, the KEOMT-K group (n = 20). The participants in both groups received 10 treatments, 2 per wk for 5 wk. Outcome Measures • The primary outcome was measured using a visual analog scale and the Laitinen scale pain ratings. The secondary outcome measured the quality of life using the short form-36 questionnaire. The participants completed the tests at baseline and postintervention. Results • After the treatments, the intervention group had significantly lower scores than the control group for pain as well as significantly higher scores for quality of life. Conclusions • Patients achieved better health benefits from manual therapy when it was combined with cryotherapy.

Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial

PubMed Central

2010-01-01

Background The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) is a registered, double-blinded, randomized, controlled trial designed to assess the efficacy of osteopathic manipulative treatment (OMT) as an adjunctive treatment in elderly patients with pneumonia. Methods 406 subjects aged ≥ 50 years hospitalized with pneumonia at 7 community hospitals were randomized using concealed allocation to conventional care only (CCO), light-touch treatment (LT), or OMT groups. All subjects received conventional treatment for pneumonia. OMT and LT groups received group-specific protocols for 15 minutes, twice daily until discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The primary outcomes were hospital length of stay (LOS), time to clinical stability, and a symptomatic and functional recovery score. Results Intention-to-treat (ITT) analysis (n = 387) found no significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant difference between groups (P = 0.01) in LOS. Multiple comparisons indicated a reduction in median LOS (95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5 [3.9-4.9] days), but not versus the LT group (3.9 [3.5-4.8] days). Secondary outcomes of duration of intravenous antibiotics and treatment endpoint were also significantly different between groups (P = 0.05 and 0.006, respectively). Duration of intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the CCO group, but not versus the LT group. Conclusions ITT analysis found no differences between groups. PP analysis found significant reductions in LOS, duration of intravenous antibiotics, and respiratory failure or death when OMT was compared to CCO. Given the prevalence of pneumonia, adjunctive OMT merits further study. PMID:20302619

Effect of Risk of Bias on the Effect Size of Meta-Analytic Estimates in Randomized Controlled Trials in Periodontology and Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Wu, Yun-Chun; Scheidgen, Moritz; Tu, Yu-Kang

2015-01-01

Background Risk of bias (ROB) may threaten the internal validity of a clinical trial by distorting the magnitude of treatment effect estimates, although some conflicting information on this assumption exists. Objective The objective of this study was evaluate the effect of ROB on the magnitude of treatment effect estimates in randomized controlled trials (RCTs) in periodontology and implant dentistry. Methods A search for Cochrane systematic reviews (SRs), including meta-analyses of RCTs published in periodontology and implant dentistry fields, was performed in the Cochrane Library in September 2014. Random-effect meta-analyses were performed by grouping RCTs with different levels of ROBs in three domains (sequence generation, allocation concealment, and blinding of outcome assessment). To increase power and precision, only SRs with meta-analyses including at least 10 RCTs were included. Meta-regression was performed to investigate the association between ROB characteristics and the magnitudes of intervention effects in the meta-analyses. Results Of the 24 initially screened SRs, 21 SRs were excluded because they did not include at least 10 RCTs in the meta-analyses. Three SRs (two from periodontology field) generated information for conducting 27 meta-analyses. Meta-regression did not reveal significant differences in the relationship of the ROB level with the size of treatment effect estimates, although a trend for inflated estimates was observed in domains with unclear ROBs. Conclusion In this sample of RCTs, high and (mainly) unclear risks of selection and detection biases did not seem to influence the size of treatment effect estimates, although several confounders might have influenced the strength of the association. PMID:26422698

Are beta-blockers effective for preventing post-coronary artery bypass grafting atrial fibrillation? Direct and network meta-analyses.

PubMed

Ji, T; Feng, C; Sun, L; Ye, X; Bai, Y; Chen, Q; Qin, Y; Zhu, J; Zhao, X

2016-05-01

Atrial fibrillation is the most common arrhythmia in clinical practice and is a major contributor to mortality. Recently, several studies have reported different results for treatments aimed at reducing the risk of postoperative AF. The aim of this study was to evaluate the efficacy of beta-blockers (BBs) in preventing post-coronary artery bypass grafting (CABG) AF and to compare the efficacies of different BB treatments using a network meta-analytical approach. The PubMed, EMBASE and Cochrane Library databases were searched (Jan 1995 to May 2014) to identify randomized controlled trials. Two independent investigators separately extracted the data using a seven-point scoring system to assess randomization, allocation concealment, blinding, withdrawals and dropouts. A direct meta-analysis of these randomized controlled trials was conducted. Then, six trials comparing different BB treatments for the prevention of postoperative AF were added to perform a Bayesian network meta-analysis with mixed treatment comparisons. Treatment with BBs was associated with a significant reduction in the postoperative incidence of AF compared with placebo/control [22.37 % compared with 34.45 %, relative risk (RR) = 0.53, 95 % confidence interval (CI): 0.37-0.75, p < 0.00001]. The network meta-analysis revealed no significant differences among eight types of BB treatments but did provide a ranking. BB treatments could significantly reduce the occurrence of post-CABG AF. Insufficient evidence was available to show that one BB treatment was more effective than the others were. According to our network meta-analysis, bisoprolol and landiolol+bisoprolol are better alternatives compared with the other treatments.

Effectiveness of Acupuncture and Electroacupuncture for Chronic Neck Pain: A Systematic Review and Meta-Analysis.

PubMed

Seo, See Yoon; Lee, Ki-Beom; Shin, Joon-Shik; Lee, Jinho; Kim, Me-Riong; Ha, In-Hyuk; Ko, Youme; Lee, Yoon Jae

2017-01-01

The aim of this systematic review was to assess evidence from randomized controlled trials (RCTs) on the effectiveness and safety of acupuncture and electroacupuncture in patients with chronic neck pain. We searched nine databases including Chinese, Japanese and Korean databases through 30 July 2016. The participants were adults with chronic neck pain and were treated with acupuncture or electroacupuncture. Eligible trials were those with intervention groups receiving acupuncture and electroacupuncture with or without active control, and control groups receiving other conventional treatments such as physical therapy or medication. Outcomes included pain intensity, disability, quality of life (QoL) and adverse effects. For statistical pooling, the standardized mean difference (SMD) and its 95% confidence interval (CI) were calculated using a fixed-effects model. Sixteen RCTs were selected. The comparison of the sole acupuncture group and the active control group did not come out with a significant difference in pain (SMD 0.24, 95% CI [Formula: see text]0.27-0.75), disability (SMD 0.51, 95% CI [Formula: see text]0.01-1.02), or QoL (SMD [Formula: see text]0.37, 95% CI [Formula: see text]1.09-0.35), showing a similar effectiveness of acupuncture with active control. When acupuncture was added into the control group, the acupuncture add-on group showed significantly higher relief of pain in studies with unclear allocation concealment (SMD [Formula: see text]1.78, 95% CI [Formula: see text]2.08-[Formula: see text]1.48), but did not show significant relief of pain in studies with good allocation concealment (SMD [Formula: see text]0.07, 95% CI [Formula: see text]0.26-0.12). Significant relief of pain was observed when the sole electroacupuncture group was compared to the control group or electroacupuncture was added onto the active control group, but a lot of the results were evaluated to have low level of evidence, making it difficult to draw clear conclusions. In the result reporting adverse effects, no serious outcome of adverse event was confirmed. Acupuncture and conventional medicine for chronic neck pain have similar effectiveness on pain and disability when compared solely between the two of them. When acupuncture was added onto conventional treatment it relieved pain better, and electroacupuncture relieved pain even more. It is difficult to draw conclusion because the included studies have a high risk of bias and imprecision. Therefore better designed large-scale studies are needed in the future.

Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste

PubMed Central

Martins, Nelson; Morris, Peter

2009-01-01

Objective To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis. Design Parallel group randomised controlled trial. Setting Three primary care clinics in Dili, Timor-Leste. Participants 270 adults aged ≥18 with previously untreated newly diagnosed pulmonary tuberculosis. Main outcome measures Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes. Results Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3). Conclusion Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required. Trial registration Clinical Trials NCT0019256. PMID:19858174

Effects of laterally wedged insoles on symptoms and disease progression in medial knee osteoarthritis: a protocol for a randomised, double-blind, placebo controlled trial

PubMed Central

Bennell, Kim; Bowles, Kelly-Ann; Payne, Craig; Cicuttini, Flavia; Osborne, Richard; Harris, Anthony; Hinman, Rana

2007-01-01

Background Whilst laterally wedged insoles, worn inside the shoes, are advocated as a simple, inexpensive, non-toxic self-administered intervention for knee osteoarthritis (OA), there is currently limited evidence to support their use. The aim of this randomised, double-blind controlled trial is to determine whether laterally wedges insoles lead to greater improvements in knee pain, physical function and health-related quality of life, and slower structural disease progression as well as being more cost-effective, than control flat insoles in people with medial knee OA. Methods/Design Two hundred participants with painful radiographic medial knee OA and varus malalignment will be recruited from the community and randomly allocated to lateral wedge or control insole groups using concealed allocation. Participants will be blinded as to which insole is considered therapeutic. Blinded follow up assessment will be conducted at 12 months after randomisation. The outcome measures are valid and reliable measures recommended for OA clinical trials. Questionnaires will assess changes in pain, physical function and health-related quality-of-life. Magnetic resonance imaging will measure changes in tibial cartilage volume. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor on a monthly basis. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of laterally wedged insoles for the management of medial knee OA. Trial registration ACTR12605000503628; NCT00415259. PMID:17892539

Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste.

PubMed

Martins, Nelson; Morris, Peter; Kelly, Paul M

2009-10-26

To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis. Parallel group randomised controlled trial. Three primary care clinics in Dili, Timor-Leste. 270 adults aged >or=18 with previously untreated newly diagnosed pulmonary tuberculosis. Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes. Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3). Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required. Clinical Trials NCT00192556.

Shoulder function and work disability after decompression surgery for subacromial impingement syndrome: a randomised controlled trial of physiotherapy exercises and occupational medical assistance.

PubMed

Svendsen, Susanne W; Christiansen, David H; Haahr, Jens Peder; Andrea, Linda C; Frost, Poul

2014-06-21

Surgery for subacromial impingement syndrome is often performed in working age and postoperative physiotherapy exercises are widely used to help restore function. A recent Danish study showed that 10% of a nationwide cohort of patients retired prematurely within two years after surgery. Few studies have compared effects of different postoperative exercise programmes on shoulder function, and no studies have evaluated workplace-oriented interventions to reduce postoperative work disability. This study aims to evaluate the effectiveness of physiotherapy exercises and occupational medical assistance compared with usual care in improving shoulder function and reducing postoperative work disability after arthroscopic subacromial decompression. The study is a mainly pragmatic multicentre randomised controlled trial. The trial is embedded in a cohort study of shoulder patients referred to public departments of orthopaedic surgery in Central Denmark Region. Patients aged ≥18-≤63 years, who still have shoulder symptoms 8-12 weeks after surgery, constitute the study population. Around 130 participants are allocated to: 1) physiotherapy exercises, 2) occupational medical assistance, 3) physiotherapy exercises and occupational medical assistance, and 4) usual care. Intervention manuals allow individual tailoring. Primary outcome measures include Oxford Shoulder Score and sickness absence due to symptoms from the operated shoulder. Randomisation is computerised with allocation concealment by randomly permuted block sizes. Statistical analyses will primarily be performed according to the intention-to-treat principle. The paper presents the rationale, design, methods, and operational aspects of the Shoulder Intervention Project (SIP). SIP evaluates a new rehabilitation approach, where physiotherapy and occupational interventions are provided in continuity of surgical episodes of care. If successful, the project may serve as a model for rehabilitation of surgical shoulder patients. Current Controlled Trials ISRCTN55768749.

A Randomized Controlled Trial of Team-Based Learning Versus Lectures with Break-Out Groups on Knowledge Retention.

PubMed

Thrall, Grace C; Coverdale, John H; Benjamin, Sophiya; Wiggins, Anna; Lane, Christianne Joy; Pato, Michele T

2016-10-01

This goal of this study was to evaluate the efficacy of team-based learning (TBL) on knowledge retention compared to traditional lectures with small break-out group discussion (teaching as usual (TAU)) using a randomized controlled trial. This randomized controlled trial was conducted during a daylong conference for psychiatric educators on attention-deficit hyperactivity disorder and the research literacy topic of efficacy versus effectiveness trials. Learners (n = 115) were randomized with concealed allocation to either TBL or TAU. Knowledge was measured prior to the intervention, immediately afterward, and 2 months later via multiple-choice tests. Participants were necessarily unblinded. Data enterers, data analysts, and investigators were blinded to group assignment in data analysis. Per-protocol analyses of test scores were performed using change in knowledge from baseline. The primary endpoint was test scores at 2 months. At baseline, there were no statistically significant differences between groups in pre-test knowledge. At immediate post-test, both TBL and TAU groups showed improved knowledge scores compared with their baseline scores. The TBL group performed better statistically on the immediate post-test than the TAU group (Cohen's d = 0.73; p < 0.001), although the differences in knowledge scores were not educationally meaningful, averaging just one additional test question correct (out of 15). On the 2-month remote post-test, there were no group differences in knowledge retention among the 42 % of participants who returned the 2-month test. Both TBL and TAU learners acquired new knowledge at the end of the intervention and retained knowledge over 2 months. At the end of the intervention day and after 2 months, knowledge test scores were not meaningfully different between TBL and TAU completers. In conclusion, this study failed to demonstrate the superiority of TBL over TAU on the primary outcome of knowledge retention at 2 months post-intervention.

Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

PubMed

Reeves, Fairleigh; Batty, Lachlan; Pitt, Veronica; Chau, Marisa; Pattuwage, Loyal; Gruen, Russell L

2013-10-01

Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future randomized controlled trials should investigate the efficacy and safety of early pharmacologic prophylaxis in addition to mechanical intervention. Systematic review, level IV.

Laparoscopic repair of incisional and ventral hernias with the new type of meshes: randomized control trial.

PubMed

Grubnik, Vladimir V; Grubnik, Aleksandra V; Vorotyntseva, Kseniya O

2014-06-01

Laparoscopic incisional and ventral hernia repair (LIVHR) was first reported by Le Blanc and Booth in 1993. Many studies are available in the literature that have shown that laparoscopic repair of incisional and ventral hernia is preferred over open repair because of lower recurrence rates (less than 10%), less wound morbidity, less pain, and early return to work. To identify the long-term outcomes between the different types of meshes and two techniques of mesh fixation, i.e., tacks (method Double crown) and transfascial polypropylene sutures. A total of 92 patients underwent LIVHR at our department between January 2009 and August 2012. The hernias were umbilical in 26 patients, paraumbilical in 15 patients and incisional in 51 patients. All patients admitted for LIVHR were randomized to either group I (tacker fixation of ePTFE meshes) or group II (suture fixation of meshes with nitinol frame) using computer-generated random numbers with block randomization and sealed envelopes for concealed allocation. The mean mesh fixation time was significantly higher in the tacker fixation group (117 ±15 min vs. 72 ±6 min, p < 0.01). There were no conversions in either group. The median postoperative hospital stay was 3.5 ±1.5 days. All patients were followed up at 1, 3, 6, 12 and every 6 months thereafter postoperatively. There were 5 recurrences in the study population. In group I there were 4 patients with recurrence, and only 1 patient in the group with meshes with a nitinol frame. Meshes of the new generation with a nitinol framework can significantly improve laparoscopic ventral hernia repair. The fixation of these meshes is very simple using 3-4 transfascial sutures. The absence of shrinkage of these meshes makes the probability of recurrence minimal. Absence of tackers allows postoperative pain to be minimized. We consider that these new meshes can significantly improve laparoscopic ventral hernia repair.

The Use of Cervical Auscultation to Predict Oropharyngeal Aspiration in Children: A Randomized Controlled Trial.

PubMed

Frakking, Thuy T; Chang, Anne B; O'Grady, Kerry-Ann F; David, Michael; Walker-Smith, Katie; Weir, Kelly A

2016-12-01

In this study, we aimed to determine if the use of cervical auscultation (CA) as an adjunct to the clinical feeding evaluation (CFE + CA) improves the reliability of predicting oropharyngeal aspiration (abbreviated to aspiration) in children. The design of the study is based on open label, randomized controlled trial with concealed allocation. Results from children (<18 years) randomized to either CFE or CFE + CA were compared to videofluoroscopic swallow study (VFSS), the reference standard data. Aspiration was defined using the Penetration-Aspiration Scale. All assessments were undertaken at a single tertiary pediatric hospital. 155 children referred for a feeding/swallowing assessment were randomized into the CFE n = 83 [38 males; mean age = 34.9 months (SD 34.4)] or CFE + CA n = 72 [43 males; mean age = 39.6 months (SD 39.3)] group. kappa statistic, sensitivity, and specificity values, area under receiver operating curve (aROC). No significant differences between groups were found, although CFE + CA (kappa = 0.41, 95 % CI 0.2-0.62) had higher agreement for aspiration detection by VFSS, compared to the clinical feeding exam alone (kappa = 0.31, 95 % CI 0.10-0.52). Sensitivity was 85 % (95 % CI 62.1-96.8) for CFE + CA and 63.6 % (95 % CI 45.1-79.6) for CFE. aROC was not significantly greater for CFE + CA (0.75, 95 % CI 0.65-0.86) than CFE (0.66, 95 % CI 0.55-0.76) across all age groups. Although using CA as an adjunct to the clinical feeding evaluation improves the sensitivity of predicting aspiration in children, it is not sensitive enough as a diagnostic tool in isolation. Given the serious implications of missing the diagnosis of aspiration, instrumental assessments (e.g., VFSS), remain the preferred standard.

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a prospective study.

PubMed

da Costa, Bruno R; Beckett, Brooke; Diaz, Alison; Resta, Nina M; Johnston, Bradley C; Egger, Matthias; Jüni, Peter; Armijo-Olivo, Susan

2017-03-03

The Cochrane risk of bias tool is commonly criticized for having a low reliability. We aimed to investigate whether training of raters, with objective and standardized instructions on how to assess risk of bias, can improve the reliability of the Cochrane risk of bias tool. In this pilot study, four raters inexperienced in risk of bias assessment were randomly allocated to minimal or intensive standardized training for risk of bias assessment of randomized trials of physical therapy treatments for patients with knee osteoarthritis pain. Two raters were experienced risk of bias assessors who served as reference. The primary outcome of our study was between-group reliability, defined as the agreement of the risk of bias assessments of inexperienced raters with the reference assessments of experienced raters. Consensus-based assessments were used for this purpose. The secondary outcome was within-group reliability, defined as the agreement of assessments within pairs of inexperienced raters. We calculated the chance-corrected weighted Kappa to quantify agreement within and between groups of raters for each of the domains of the risk of bias tool. A total of 56 trials were included in our analysis. The Kappa for the agreement of inexperienced raters with reference across items of the risk of bias tool ranged from 0.10 to 0.81 for the minimal training group and from 0.41 to 0.90 for the standardized training group. The Kappa values for the agreement within pairs of inexperienced raters across the items of the risk of bias tool ranged from 0 to 0.38 for the minimal training group and from 0.93 to 1 for the standardized training group. Between-group differences in Kappa for the agreement of inexperienced raters with reference always favored the standardized training group and was most pronounced for incomplete outcome data (difference in Kappa 0.52, p < 0.001) and allocation concealment (difference in Kappa 0.30, p = 0.004). Intensive, standardized training on risk of bias assessment may significantly improve the reliability of the Cochrane risk of bias tool.

Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial.

PubMed

Han, Gajin; Leem, Jungtae; Lee, Hojung; Lee, Junhee

2016-05-17

Gastroesophageal reflux disease lowers the quality of life and increases medical costs. Electroacupuncture has been used to ease symptoms and improve gastrointestinal motility in patients with gastroesophageal reflux disease. The main purposes of this study are to evaluate the efficacy and safety of this procedure. This is a protocol for a randomized, patient-blinded, assessor-blinded, sham-controlled trial. Sixty participants with symptoms of gastroesophageal reflux disease, who have previously undergone standard treatment, will be recruited from August 2015 at Kyung Hee University Korean Medicine Hospital. The participants will be allocated to either the electroacupuncture (n = 30) or the sham electroacupuncture group (n = 30); the allocation will be concealed from both the participants and the assessors. The EA group will undergo penetrating acupuncture at 18 fixed points and two optional points chosen using the pattern identification for gastroesophageal reflux disease. Electrical stimulation will be applied at some of the acupoints. The sham electroacupuncture group will undergo nonpenetrating acupuncture without electrical stimulation at 18 nonspecific points, each of which will be only 2 cm away from the true acupoints used in the electroacupuncture group. In both groups, the procedure will be performed using the Park device. The treatment will last for 6 weeks (with two sessions each week), and the outcome will be evaluated at baseline, 3 weeks, and 6 weeks. The primary outcome will be the proportion of responders with adequate symptom relief, whereas the secondary outcomes will comprise the results of the Nepean dyspepsia index; the Korean gastrointestinal symptom rating scale; the EQ-5D™; levels of gastrin, motilin, and inflammatory cytokines; the perceived stress scale; the qi-stagnation questionnaire; the patient global impression of change; and the spleen qi deficiency questionnaire. The results of this trial will provide information about the efficacy and safety of electroacupuncture in the treatment of gastroesophageal reflux disease symptoms, as well as evidence regarding the use of electroacupuncture to treat gastroesophageal reflux disease in real clinical practice. Clinical Research Information Service Identifier, KCT0001653 . Registered on 12 October 2015.

Comparison of secure messaging application (WhatsApp) and standard telephone usage for consultations on Length of Stay in the ED. A prospective randomized controlled study.

PubMed

Gulacti, Umut; Lok, Ugur

2017-07-19

Consultation, the process of an Emergency Physician seeking an opinion from other specialties, occurs frequently in the Emergency Department (ED). The aim of this study was to determine the effect of secure messaging application (WhatsApp) usage for medical consultations on Emergency Department Length of Stay (ED LOS) and consult time. We conducted a prospective, randomized controlled trial in the ED using allocation concealment over three months. Consultations requested in the ED were allocated into two groups: consultations requested via the secure messaging application and consultations requested by telephone as verbal. A total of 439 consultations requested in the ED were assessed for eligibility and 345 were included in the final analysis: 173 consultations were conducted using secure messaging application and 172 consultations were conducted using standard telephone communications. The median ED LOS was 240 minutes (IQR:230-270, 95% CI:240 to 255.2) for patients in the secure messaging application group and 277 minutes (IQR:270-287.8, 95% CI:277 to 279) for patients in the telephone group. The median total ED LOS was significantly lower among consults conducted using Secure messaging application relative to consults conducted by telephone (median dif: -30, 95%CI:-37to-25, p<0.0001). The median consult time was 158 minutes (IQR:133 to 177.25, 95% CI:150 to 169) for patients in the Secure messaging application group and 170 minutes (IQR:165 to 188.5, 95% CI:170-171) for patients in the Telephone group (median dif: -12, 95%CI:-19 to-7,p<0.0001). Consultations completed without ED arrival was 61.8% in the secure messaging group and 33.1% in the Telephone group (dif: 28.7, 95% CI:48.3 to 66, p<0.001). Use of secure messaging application for consultations in the ED reduces the total ED LOS and consultation time. Consultation with secure messaging application eliminated more than half of in-person ED consultation visits.

Photodynamic therapy for chronic periodontitis.

PubMed

Herrera, David

2011-01-01

Medline, Embase, The Cochrane Oral Health Group's Trials Register, CENTRAL, UK National Research Register, ISI Proceedings, hand search of relevant journals for 2000-2008. References from selected articles and contact with authors. Randomised controlled trials in any language comparing scaling and root planing (SRP) alone and SRP with PDT in patients with chronic periodontitis, with a mean follow up of at least 12 weeks. The primary outcome measure was the change in clinical attachment loss (CAL). Secondary outcomes were changes in probing depth (PD) and gingival recession (GR). Data were extracted by a single reviewer using a standard extraction form. Quality was assessed using both the Jadad scale and the allocation concealment component of the Cochrane risk of bias tool. Meta-analysis was conducted using the random effects model. Heterogeneity was assessed using the chi-squared-based Q statistic method and Higgins' I(2) test. Four trials with 101 participants were included. The risk of bias of these trials was considered to be moderate. The mean difference in CAL at 12 weeks was 0.29 mm (95% CI 0.08-0.50, p=0.007). Heterogeneity was high using both the Chi(2) and I(2) tests. The review suggests there may be a minor improvement in clinical attachment loss at 12 weeks. It is unclear whether this is a clinically meaningful improvement.

Systematic reviews identify important methodological flaws in stroke rehabilitation therapy primary studies: review of reviews.

PubMed

Santaguida, Pasqualina; Oremus, Mark; Walker, Kathryn; Wishart, Laurie R; Siegel, Karen Lohmann; Raina, Parminder

2012-04-01

A "review of reviews" was undertaken to assess methodological issues in studies evaluating nondrug rehabilitation interventions in stroke patients. MEDLINE, CINAHL, PsycINFO, and the Cochrane Database of Systematic Reviews were searched from January 2000 to January 2008 within the stroke rehabilitation setting. Electronic searches were supplemented by reviews of reference lists and citations identified by experts. Eligible studies were systematic reviews; excluded citations were narrative reviews or reviews of reviews. Review characteristics and criteria for assessing methodological quality of primary studies within them were extracted. The search yielded 949 English-language citations. We included a final set of 38 systematic reviews. Cochrane reviews, which have a standardized methodology, were generally of higher methodological quality than non-Cochrane reviews. Most systematic reviews used standardized quality assessment criteria for primary studies, but not all were comprehensive. Reviews showed that primary studies had problems with randomization, allocation concealment, and blinding. Baseline comparability, adverse events, and co-intervention or contamination were not consistently assessed. Blinding of patients and providers was often not feasible and was not evaluated as a source of bias. The eligible systematic reviews identified important methodological flaws in the evaluated primary studies, suggesting the need for improvement of research methods and reporting. Copyright © 2012 Elsevier Inc. All rights reserved.

A comparative study of restricted randomization procedures for multiarm trials with equal or unequal treatment allocation ratios.

PubMed

Ryeznik, Yevgen; Sverdlov, Oleksandr

2018-06-04

Randomization designs for multiarm clinical trials are increasingly used in practice, especially in phase II dose-ranging studies. Many new methods have been proposed in the literature; however, there is lack of systematic, head-to-head comparison of the competing designs. In this paper, we systematically investigate statistical properties of various restricted randomization procedures for multiarm trials with fixed and possibly unequal allocation ratios. The design operating characteristics include measures of allocation balance, randomness of treatment assignments, variations in the allocation ratio, and statistical characteristics such as type I error rate and power. The results from the current paper should help clinical investigators select an appropriate randomization procedure for their clinical trial. We also provide a web-based R shiny application that can be used to reproduce all results in this paper and run simulations under additional user-defined experimental scenarios. Copyright © 2018 John Wiley & Sons, Ltd.

Personality traits predict treatment outcome with an antidepressant in patients with functional gastrointestinal disorder.

PubMed

Tanum, L; Malt, U F

2000-09-01

We investigated the relationship between personality traits and response to treatment with the tetracyclic antidepressant mianserin or placebo in patients with functional gastrointestinal disorder (FGD) without psychopathology. Forty-eight patients completed the Buss-Durkee Hostility Inventory, Neuroticism Extroversion Openness -Personality Inventory (NEO-PI), and Eysenck Personality Questionnaire (EPQ), neuroticism + lie subscales, before they were consecutively allocated to a 7-week double-blind treatment study with mianserin or placebo. Treatment response to pain and target symptoms were recorded daily with the Visual Analogue Scale and Clinical Global Improvement Scale at every visit. A low level of neuroticism and little concealed aggressiveness predicted treatment outcome with the antidepressant drug mianserin in non-psychiatric patients with FGD. Inversely, moderate to high neuroticism and marked concealed aggressiveness predicted poor response to treatment. These findings were most prominent in women. Personality traits were better predictors of treatment outcome than serotonergic sensitivity assessed with the fenfluramine test. Assessment of the personality traits negativism, irritability, aggression, and neuroticism may predict response to drug treatment of FGD even when serotonergic sensitivity is controlled for. If confirmed in future studies, the findings point towards a more differential psychopharmacologic treatment of FGD.

Coevolution of female ovulatory signals and male-male competition in primates.

PubMed

Nakahashi, Wataru

2016-03-07

Visual signals of ovulation vary among primate species. Although slight ovulatory signals are considered primate ancestral traits of which some species still exhibit, some show prominent swelling of their perineal skin (exaggerated sexual swellings) and others do not exhibit any signals of ovulation (concealed ovulation). These signals strongly affect male mating behaviors. I develop an evolutionary model of female ovulatory signals and male-male competition. I assume that each male allocates his effort between attraction of females and male-male competition for dominance. Each female gains a benefit if she is fertile and free from the alpha male who always guards one of the most fertile females in the group, but suffers a cost if she expresses a different ovulatory signal from an ancestral trait. I show that various types of ovulatory signals may evolve and can be multistable. Male-male competition becomes intense when the signal honestly indicates ovulation. Ovulatory signals may evolve to be less exaggerated in unimale groups than in multimale groups and monogamy is more likely to evolve when ovulation is concealed. These results may partly explain why various types of primate ovulatory signals evolved and how they have affected primate societies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Do virtual reality games improve mobility skills and balance measurements in community-dwelling older adults? Systematic review and meta-analysis.

PubMed

Neri, Silvia Gr; Cardoso, Jefferson R; Cruz, Lorena; Lima, Ricardo M; de Oliveira, Ricardo J; Iversen, Maura D; Carregaro, Rodrigo L

2017-10-01

To summarize evidence on the effectiveness of virtual reality games and conventional therapy or no-intervention for fall prevention in the elderly. An electronic data search (last searched December 2016) was performed on 10 databases (Web of Science, EMBASE, PUBMED, CINAHL, LILACS, SPORTDiscus, Cochrane Library, Scopus, SciELO, PEDro) and retained only randomized controlled trials. Sample characteristics and intervention parameters were compared, focusing on clinical homogeneity of demographic characteristics, type/duration of interventions, outcomes (balance, reaction time, mobility, lower limb strength and fear of falling) and low risk of bias. Based on homogeneity, a meta-analysis was considered. Two independent reviewers assessed the risk of bias. A total of 28 studies met the inclusion criteria and were appraised ( n: 1121 elderly participants). We found that virtual reality games presented positive effects on balance and fear of falling compared with no-intervention. Virtual reality games were also superior to conventional interventions for balance improvements and fear of falling. The six studies included in the meta-analysis demonstrated that virtual reality games significantly improved mobility and balance after 3-6 and 8-12 weeks of intervention when compared with no-intervention. The risk of bias revealed that less than one-third of the studies correctly described the random sequence generation and allocation concealment procedures. Our review suggests positive clinical effects of virtual reality games for balance and mobility improvements compared with no-treatment and conventional interventions. However, owing to the high risk of bias and large variability of intervention protocols, the evidence remains inconclusive and further research is warranted.

Effectiveness of Musculoskeletal Education Interventions in People With Low Literacy Levels: A Systematic Review

PubMed Central

Lowe, Wendy; Ballinger, Claire; Protheroe, Jo; Lueddeke, Jill; Nutbeam, Don; Armstrong, Ray; Falzon, Louise; Edwards, Chris; Russell, Cynthia; McCaffery, Kirsten; Adams, Jo

2013-01-01

Objective To conduct a systematic review to assess the effectiveness of patient education interventions delivered or directed by health professionals for people with musculoskeletal conditions who also have lower levels of literacy. Methods Electronic databases were searched from 1946 to May 2012. Randomized controlled trials with primary interventions designed specifically for individuals with musculoskeletal conditions and lower levels of literacy were eligible for inclusion. The quality of the study was determined by assessing method of randomization, allocation concealment, creation and maintenance of comparable groups, blinding of patients and providers, control of confounding, and the validity and reliability of outcome measures. Results Of the 2,440 studies located using the search strategy, 6 studies met the inclusion criteria. Three public health community studies and 3 rheumatology clinic-based studies delivered educational programs to people with musculoskeletal conditions who also had lower levels of literacy. Three moderate quality studies suggest that musculoskeletal educational interventions had a small short-term effect on knowledge and 2 moderate quality studies suggest musculoskeletal interventions had a small effect on self-efficacy (although results on self-efficacy were conflicting in 1 of these studies). Only 1 moderate quality study showed a small effect on anxiety and 1 on self-perceived health and well-being in people with lower literacy. Conclusion High quality evidence is lacking on the effectiveness of musculoskeletal education interventions for people with lower literacy levels. Research programs that test the effectiveness of patient education interventions for arthritis must recruit and engage people with lower levels of literacy. PMID:23925869

Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial

PubMed Central

Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi

2017-01-01

Background The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). Objective To describe the data management process and statistical analysis plan. Methods The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. Conclusion According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. Trial registration ClinicalTrials.gov number, NCT01374022. PMID:28977255

Functional training reduces body fat and improves functional fitness and cholesterol levels in postmenopausal women: a randomized clinical trial.

PubMed

Neves, Lucas M; Fortaleza, Ana C; Rossi, Fabrício E; Diniz, Tiego A; Codogno, Jamile S; Gobbo, Luis A; Gobbi, Sebastião; Freitas, Ismael F

2017-04-01

This randomized clinical trial with concealed allocations, and blinding of the assessors and the data analyst, was aimed at determining the effects of 16 weeks of functional training on the body composition, functional fitness and lipid profiles in postmenopausal women. The study began with 64 subjects (N.=32 functional training and N.=32 control group) and ended with 50 subjects (N.=28 functional training and N.=22 control group). The exercise was conducted in circuit training format with 8 stations related to the development of muscular strength (using elastic bands for resistance) plus 3 stations focused on balance, coordination, and agility. The training session also incorporated an 18 to 30 minute walk. The control group did not participate in the exercise programs during the period of study. The participants were evaluated before and after the training period as regards their body composition (fat and lean mass), functional fitness, abdominal strength and blood chemistry variables. Significant reductions were observed in all body composition variables related to fat (FM= -3.4 and Android FM= -7.7%) (P<0.05). The functional fitness components had significant improvements in coordination (-33.3%), strength (66.5%), agility (-19.5%) and aerobic capacity (-7%), and significant improvement in abdominal strength (188.2%). We observed significant improvements in total cholesterol (-4.4%) and HDL (-9.9%). The observed data lead us to conclude that functional training utilizing with elastic bands and unstable bases causes significantly improved in body composition, functional fitness and lipid profiles.

The impact of neutral-pH peritoneal dialysates with reduced glucose degradation products on clinical outcomes in peritoneal dialysis patients.

PubMed

Cho, Yeoungjee; Johnson, David W; Badve, Sunil V; Craig, Jonathan C; Strippoli, Giovanni F M; Wiggins, Kathryn J

2013-11-01

Neutral-pH peritoneal dialysates, with reduced glucose degradation products (GDPs), have been developed to reduce peritoneal membrane damage. Here our review evaluated the impact of these solutions on clinical outcomes using data from The Cochrane CENTRAL Registry, MEDLINE, Embase, and reference lists for randomized trials of biocompatible solutions. Summary estimates of effect were obtained using a random-effects model of 20 eligible trials encompassing 1383 patients. The quality of studies was generally poor, such that 13 studies had greater than a 20% loss to follow-up and only 3 trials reported adequate concealment of allocation. Use of neutral-pH dialysates with reduced GDPs resulted in larger urine volumes (7 trials; 520 patients; mean difference 126 ml/day, 95% CI 27-226), improved residual renal function after 12 months (6 trials; 360 patients; standardized mean difference 0.31, 95% confidence interval 0.10-0.52), and a trend to reduced inflow pain (1 trial; 58 patients; relative risk 0.51, 95% CI 0.24-1.08). However, there was no significant effect on body weight, hospitalization, peritoneal solute transport rate, peritoneal small-solute clearance, peritonitis, technique failure, patient survival, or adverse events. No significant harms were identified. Thus, based on generally poor quality trials, the use of neutral-pH peritoneal dialysates with reduced GDPs resulted in greater urine volumes and residual renal function after 12 months, but without other clinical benefits. Larger, better-quality studies are needed for accurate evaluation of the impact of these newer dialysates on patient-level hard outcomes.

Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial.

PubMed

Bartholdy, Savani; McClelland, Jessica; Kekic, Maria; O'Daly, Owen G; Campbell, Iain C; Werthmann, Jessica; Rennalls, Samantha J; Rubia, Katya; David, Anthony S; Glennon, Danielle; Kern, Nikola; Schmidt, Ulrike

2015-12-03

Anorexia nervosa (AN) is a serious mental disorder with multiple comorbidities and complications. In those with a severe and enduring form of the illness (SEED-AN), treatment responsivity is poor and the evidence base limited. Thus, there is a need for novel treatment strategies. This paper describes the theoretical background and protocol of a feasibility randomised controlled trial (RCT) of real versus sham (placebo) therapeutic repetitive transcranial magnetic stimulation (rTMS) in SEED-AN. The aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of rTMS in this group of patients, and also to assess the preliminary efficacy and neural correlates of rTMS treatment. Forty-four adults from the community with a DSM-5 diagnosis of AN, an illness duration>3 years and a previous course of unsuccessful treatment will be randomly allocated to receive 20 sessions of either real or sham rTMS, in a parallel group design. As this is a feasibility study, no primary outcome has been defined and a broad range of outcome variables will be examined. These include weight/body mass index (BMI), eating disorder psychopathology, other psychopathology (for example, depression, anxiety), quality of life, neuropsychological processes (such as self-regulation, attentional bias and food choice behaviour), neuroimaging measures (that is, changes in brain structure or function), tolerability and acceptability of rTMS, and additional service utilisation. The feasibility of conducting a large-scale RCT of rTMS and the appropriateness of rTMS as a treatment for SEED-AN will be evaluated through: assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up assessments). The acceptability and tolerability of the treatment will be assessed via semi-structured interviews. The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. Additionally, results from this study will provide a preliminary indication of the efficacy of rTMS treatment for AN, the neural correlates of the illness, and potential biomarkers of clinical response. ISRCTN14329415 . Date of registration: 23 July 2015.

Balance circuit classes to improve balance among rehabilitation inpatients: a protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Impaired balance and mobility are common among rehabilitation inpatients. Poor balance and mobility lead to an increased risk of falling. Specific balance exercise has been shown to improve balance and reduce falls within the community setting. However few studies have measured the effects of balance exercises on balance within the inpatient setting. The aim of this randomised controlled trial is to investigate whether the addition of circuit classes targeting balance to usual therapy lead to greater improvements in balance among rehabilitation inpatients than usual therapy alone. Methods/Design A single centre, randomised controlled trial with concealed allocation, assessor blinding and intention-to-treat analysis. One hundred and sixty two patients admitted to the general rehabilitation ward at Bankstown-Lidcombe Hospital will be recruited. Eligible participants will have no medical contraindications to exercise and will be able to: fully weight bear; stand unaided independently for at least 30 seconds; and participate in group therapy sessions with minimal supervision. Participants will be randomly allocated to an intervention group or usual-care control group. Both groups will receive standard rehabilitation intervention that includes physiotherapy mobility training and exercise for at least two hours on each week day. The intervention group will also receive six 1-hour circuit classes of supervised balance exercises designed to maximise the ability to make postural adjustments in standing, stepping and walking. The primary outcome is balance. Balance will be assessed by measuring the total time the participant can stand unsupported in five different positions; feet apart, feet together, semi-tandem, tandem and single-leg-stance. Secondary outcomes include mobility, self reported physical functioning, falls and hospital readmissions. Performance on the outcome measures will be assessed before randomisation and at two-weeks and three-months after randomisation by physiotherapists unaware of intervention group allocation. Discussion This study will determine the impact of additional balance circuit classes on balance among rehabilitation inpatients. The results will provide essential information to guide evidence-based physiotherapy at the study site as well as across other rehabilitation inpatient settings. Trial registration The protocol for this study is registered with the Australian New Zealand, Clinical Trials Registry: ACTRN=12611000412932 PMID:23870654

Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer.

PubMed

Walker, Jane; Hansen, Christian Holm; Martin, Paul; Symeonides, Stefan; Gourley, Charlie; Wall, Lucy; Weller, David; Murray, Gordon; Sharpe, Michael

2014-09-01

The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care. Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0-4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964. 142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference -0·38 (95% CI -0·58 to -0·18); standardised mean difference -0·62 (95% CI -0·94 to -0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group. Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy. Cancer Research UK and Chief Scientist Office of the Scottish Government. Copyright © 2014 Elsevier Ltd. All rights reserved.

Strategies for nest-site selection by king eiders

USGS Publications Warehouse

Bentzen, R.L.; Powell, A.N.; Suydam, R.S.

2009-01-01

Nest site selection is a critical component of reproduction and has presumably evolved in relation to predation, local resources, and microclimate. We investigated nest-site choice by king eiders (Somateria spectabilis) on the coastal plain of northern Alaska, USA, 2003-2005. We hypothesized that nest-site selection is driven by predator avoidance and that a variety of strategies including concealment, seclusion, and conspecific or inter-specific nest defense might lead to improved nesting success. We systematically searched wetland basins for king eider nests and measured habitat and social variables at nests (n = 212) and random locations (n = 493). King eiders made use of both secluded and concealed breeding strategies; logistic regression models revealed that females selected nests close to water, on islands, and in areas with high willow (Salix spp.) cover but did not select sites near conspecific or glaucous gull (Larus hyperboreus) nests. The most effective nest-placement strategy may vary depending on density and types of nest predators; seclusion is likely a mammalian-predator avoidance tactic whereas concealment may provide protection from avian predators. We recommend that managers in northern Alaska attempt to maintain wetland basins with islands and complex shorelines to provide potential nest sites in the vicinity of water. ?? The Wildlife Society.

The effects of growth hormone on body composition and physical performance in recreational athletes: a randomized trial.

PubMed

Meinhardt, Udo; Nelson, Anne E; Hansen, Jennifer L; Birzniece, Vita; Clifford, David; Leung, Kin-Chuen; Graham, Kenneth; Ho, Ken K Y

2010-05-04

Growth hormone is widely abused by athletes, frequently with androgenic steroids. Its effects on performance are unclear. To determine the effect of growth hormone alone or with testosterone on body composition and measures of performance. Randomized, placebo-controlled, blinded study of 8 weeks of treatment followed by a 6-week washout period. Randomization was computer-generated with concealed allocation. (Australian-New Zealand Clinical Trials Registry registration number: ACTRN012605000508673) Clinical research facility in Sydney, Australia. 96 recreationally trained athletes (63 men and 33 women) with a mean age of 27.9 years (SD, 5.7). Men were randomly assigned to receive placebo, growth hormone (2 mg/d subcutaneously), testosterone (250 mg/wk intramuscularly), or combined treatments. Women were randomly assigned to receive either placebo or growth hormone (2 mg/d). Body composition variables (fat mass, lean body mass, extracellular water mass, and body cell mass) and physical performance variables (endurance [maximum oxygen consumption], strength [dead lift], power [jump height], and sprint capacity [Wingate value]). Body cell mass was correlated with all measures of performance at baseline. Growth hormone significantly reduced fat mass, increased lean body mass through an increase in extracellular water, and increased body cell mass in men when coadministered with testosterone. Growth hormone significantly increased sprint capacity, by 0.71 kJ (95% CI, 0.1 to 1.3 kJ; relative increase, 3.9% [CI, 0.0% to 7.7%]) in men and women combined and by 1.7 kJ (CI, 0.5 to 3.0 kJ; relative increase, 8.3% [CI, 3.0% to 13.6%]) when coadministered with testosterone to men; other performance measures did not significantly change. The increase in sprint capacity was not maintained 6 weeks after discontinuation of the drug. Growth hormone dosage may have been lower than that used covertly by competitive athletes. The athletic significance of the observed improvements in sprint capacity is unclear, and the study was too small to draw conclusions about safety. Growth hormone supplementation influenced body composition and increased sprint capacity when administered alone and in combination with testosterone. The World Anti-Doping Agency.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial.

PubMed

Ang, Marcus; Tan, Donald; Mehta, Jodhbir S

2012-05-31

Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Clinicaltrials.gov NCT01216475.

Perioperative Cognitive Protection-Cognitive Exercise and Cognitive Reserve (The Neurobics Trial): A Single-blind Randomized Trial.

PubMed

Humeidan, Michelle L; Otey, Andrew; Zuleta-Alarcon, Alix; Mavarez-Martinez, Ana; Stoicea, Nicoleta; Bergese, Sergio

2015-12-01

The Neurobics Trial is a single-blind, parallel-group, randomized, controlled trial. The main study objective is to compare effectiveness of preoperative cognitive exercise versus no intervention for lowering the incidence of postoperative delirium. Enrollment began March 2015 and is ongoing. Eligible participants include patients older than 60 years of age scheduled for nonemergent, noncardiac, nonneurological surgery at our institution. Patients provide consent and are screened at our Outpatient Preoperative Assessment Clinic to rule out preexisting cognitive dysfunction, significant mental health disorders, and history of surgery requiring general anesthesia in the preceding 6 months. Participants meeting criteria are randomized to complete 1 hour daily of electronic tablet-based cognitive exercise for 10 days before surgery or no preoperative intervention. Compliance with the effective dose of 10 total hours of preoperative exercise is verified on return of the patient for surgery with time logs created by the software application and by patient self-reporting. After surgery, patients are evaluated for delirium in the postanesthesia recovery area, and then twice daily for the remainder of their hospitalization. Additionally, postoperative quality of recovery is assessed daily, along with pain scores and opiate use. More comprehensive cognitive assessments are completed just before discharge for baseline comparison, and quality of recovery is assessed via telephone interview 7, 30, and 90 days post-surgery. The primary outcome is the incidence of delirium during the postoperative hospitalization period. Randomization is computer generated, with allocation concealment in opaque envelopes. All postoperative assessments are completed by blinded study personnel. The study is actively recruiting with 19 patients having provided consent to date, and a total of 264 patients is required for study completion; therefore, no data analysis is currently under way (www.clinicaltrials.gov; NCT02230605). To our knowledge, the Neurobics Trial is the first randomized, controlled study to investigate the effectiveness of a significant preoperative cognitive exercise regimen for the prevention of delirium after noncardiac, nonneurological surgery in elderly patients. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

Quantum Image Steganography and Steganalysis Based On LSQu-Blocks Image Information Concealing Algorithm

NASA Astrophysics Data System (ADS)

A. AL-Salhi, Yahya E.; Lu, Songfeng

2016-08-01

Quantum steganography can solve some problems that are considered inefficient in image information concealing. It researches on Quantum image information concealing to have been widely exploited in recent years. Quantum image information concealing can be categorized into quantum image digital blocking, quantum image stereography, anonymity and other branches. Least significant bit (LSB) information concealing plays vital roles in the classical world because many image information concealing algorithms are designed based on it. Firstly, based on the novel enhanced quantum representation (NEQR), image uniform blocks clustering around the concrete the least significant Qu-block (LSQB) information concealing algorithm for quantum image steganography is presented. Secondly, a clustering algorithm is proposed to optimize the concealment of important data. Finally, we used Con-Steg algorithm to conceal the clustered image blocks. Information concealing located on the Fourier domain of an image can achieve the security of image information, thus we further discuss the Fourier domain LSQu-block information concealing algorithm for quantum image based on Quantum Fourier Transforms. In our algorithms, the corresponding unitary Transformations are designed to realize the aim of concealing the secret information to the least significant Qu-block representing color of the quantum cover image. Finally, the procedures of extracting the secret information are illustrated. Quantum image LSQu-block image information concealing algorithm can be applied in many fields according to different needs.

Self-Concealment and Suicidal Behaviors

ERIC Educational Resources Information Center

Friedlander, Adam; Nazem, Sarra; Fiske, Amy; Nadorff, Michael R.; Smith, Merideth D.

2012-01-01

Understanding self-concealment, the tendency to actively conceal distressing personal information from others, may be important in developing effective ways to help individuals with suicidal ideation. No published study has yet assessed the relation between self-concealment and suicidal behaviors. Additionally, most self-concealment research has…

Weighted re-randomization tests for minimization with unbalanced allocation.

PubMed

Han, Baoguang; Yu, Menggang; McEntegart, Damian

2013-01-01

Re-randomization test has been considered as a robust alternative to the traditional population model-based methods for analyzing randomized clinical trials. This is especially so when the clinical trials are randomized according to minimization, which is a popular covariate-adaptive randomization method for ensuring balance among prognostic factors. Among various re-randomization tests, fixed-entry-order re-randomization is advocated as an effective strategy when a temporal trend is suspected. Yet when the minimization is applied to trials with unequal allocation, fixed-entry-order re-randomization test is biased and thus compromised in power. We find that the bias is due to non-uniform re-allocation probabilities incurred by the re-randomization in this case. We therefore propose a weighted fixed-entry-order re-randomization test to overcome the bias. The performance of the new test was investigated in simulation studies that mimic the settings of a real clinical trial. The weighted re-randomization test was found to work well in the scenarios investigated including the presence of a strong temporal trend. Copyright © 2013 John Wiley & Sons, Ltd.

Some practical problems in implementing randomization.

PubMed

Downs, Matt; Tucker, Kathryn; Christ-Schmidt, Heidi; Wittes, Janet

2010-06-01

While often theoretically simple, implementing randomization to treatment in a masked, but confirmable, fashion can prove difficult in practice. At least three categories of problems occur in randomization: (1) bad judgment in the choice of method, (2) design and programming errors in implementing the method, and (3) human error during the conduct of the trial. This article focuses on these latter two types of errors, dealing operationally with what can go wrong after trial designers have selected the allocation method. We offer several case studies and corresponding recommendations for lessening the frequency of problems in allocating treatment or for mitigating the consequences of errors. Recommendations include: (1) reviewing the randomization schedule before starting a trial, (2) being especially cautious of systems that use on-demand random number generators, (3) drafting unambiguous randomization specifications, (4) performing thorough testing before entering a randomization system into production, (5) maintaining a dataset that captures the values investigators used to randomize participants, thereby allowing the process of treatment allocation to be reproduced and verified, (6) resisting the urge to correct errors that occur in individual treatment assignments, (7) preventing inadvertent unmasking to treatment assignments in kit allocations, and (8) checking a sample of study drug kits to allow detection of errors in drug packaging and labeling. Although we performed a literature search of documented randomization errors, the examples that we provide and the resultant recommendations are based largely on our own experience in industry-sponsored clinical trials. We do not know how representative our experience is or how common errors of the type we have seen occur. Our experience underscores the importance of verifying the integrity of the treatment allocation process before and during a trial. Clinical Trials 2010; 7: 235-245. http://ctj.sagepub.com.

Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol.

PubMed

Figueras, Francesc; Gratacos, Eduard; Rial, Marta; Gull, Ilan; Krofta, Ladislav; Lubusky, Marek; Cruz-Martinez, Rogelio; Cruz-Lemini, Mónica; Martinez-Rodriguez, Miguel; Socias, Pamela; Aleuanlli, Cristina; Cordero, Mauro C Parra

2017-06-15

Fetal growth restriction (FGR) affects 5%-10% of all pregnancies, contributing to 30%-50% of stillbirths. Unfortunately, growth restriction often is not detected antenatally. The last weeks of pregnancy are critical for preventing stillbirth among babies with FGR because there is a pronounced increase in stillbirths among growth-restricted fetuses after 37 weeks of pregnancy. Here we present a protocol (V.1, 23 May 2016) for the RATIO37 trial, which evaluates an integrated strategy for accurately selecting at-risk fetuses for delivery at term. The protocol is based on the combination of fetal biometry and cerebroplacental ratio (CPR). The primary objective is to reduce stillbirth rates. The secondary aims are to detect low birth weights and adverse perinatal outcomes. The study is designed as multicentre (Spain, Chile, Mexico,Czech Republic and Israel), open-label, randomised trial with parallel groups. Singleton pregnancies will be invited to participate after routine second-trimester ultrasound scan (19 +0 -22 +6 weeks of gestation), and participants will be randomly allocated to receive revealed or concealed CPR evaluation. Then, a routine ultrasound and Doppler scan will be performed at 36 +0 -37 +6 weeks. Sociodemographic and clinical data will be collected at enrolment. Ultrasound and Doppler variables will be recorded at 36 +0 -37 +6 weeks of pregnancy. Perinatal outcomes will be recorded after delivery. Univariate (with estimated effect size and its 95% CI) and multivariate (mixed-effects logistic regression) comparisons between groups will be performed. The study will be conducted in accordance with the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 23May 2016. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences. NCT02907242; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial.

PubMed

You, John J; Liu, Yudong; Kirby, John; Vora, Parag; Moayyedi, Paul

2015-07-09

No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial. Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding. A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64%) subjects allocated to FOBT (95% confidence interval [CI], 52-75%), 53 (80%) subjects allocated to OC (95% CI, 69-88%), and 50 (77%) subjects allocated to VC (95% CI, 65-85%); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0%) subjects allocated to FOBT, 12 (18%) subjects allocated to OC, and 2 (3%) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer. In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80% of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening. ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527.

A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India.

PubMed

Mody, Gita N; Nirmal, Ida Anita; Duraisamy, Sulochana; Perakath, Benjamin

2008-12-01

Wound closure using topical negative pressure (TNP) has been reported to be effective, but equipment costs can be prohibitive in resource-challenged countries. Because nonhealing wounds are exceedingly common in developing countries such as India, the ability to optimize wound care with limited resources is very important. To investigate the feasibility and efficacy of providing TNP in an Indian medical referral center, a randomized controlled trial comparing a locally constructed TNP device (treatment) to wet-to-dry gauze dressings (control) was conducted. Eligible study participants (N = 48) were recruited from the inpatient wards. Wound etiologies included diabetic foot ulcers (15), pressure ulcers (11), cellulitis/fasciitis (11), and "other" (11). Following enrollment, wound size was assessed using computer-aided measurements of digital photographs and block-randomized to the study arms using a concealed allocation table. Wounds in both treatment groups were débrided before dressing application and patients were followed until wound closure or being lost to follow-up for an average of 26.3 days (+/- 18.5) in the control and 33.1 days (+/- 37.3) in the treatment group. No statistically significant differences in time to closure between the two treatment groups were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for treatment and 27 +/- 10.6 days in control group, P = 0.05). Direct costs to close a pressure ulcer also were lower in the TNP than in the control group. A review of the literature suggests the outcomes obtained using a locally constructed TNP device are similar to those obtained using commercially available devices. As a result of this study, a dedicated tissue viability team has been established to identify wounds suitable for TNP, oversee treatment, monitor the need for surgical débridement, and employ wound healing principles and technology appropriately. These results suggest that inexpensive materials can be utilized for TNP wound closure in a developing country.

Adjudication-related processes are underreported and lack standardization in clinical trials of venous thromboembolism: a systematic review.

PubMed

Stuck, Anna K; Fuhrer, Evelyn; Limacher, Andreas; Méan, Marie; Aujesky, Drahomir

2014-03-01

Although the use of an adjudication committee (AC) for outcomes is recommended in randomized controlled trials, there are limited data on the process of adjudication. We therefore aimed to assess whether the reporting of the adjudication process in venous thromboembolism (VTE) trials meets existing quality standards and which characteristics of trials influence the use of an AC. We systematically searched MEDLINE and the Cochrane Library from January 1, 2003, to June 1, 2012, for randomized controlled trials on VTE. We abstracted information about characteristics and quality of trials and reporting of adjudication processes. We used stepwise backward logistic regression model to identify trial characteristics independently associated with the use of an AC. We included 161 trials. Of these, 68.9% (111 of 161) reported the use of an AC. Overall, 99.1% (110 of 111) of trials with an AC used independent or blinded ACs, 14.4% (16 of 111) reported how the adjudication decision was reached within the AC, and 4.5% (5 of 111) reported on whether the reliability of adjudication was assessed. In multivariate analyses, multicenter trials [odds ratio (OR), 8.6; 95% confidence interval (CI): 2.7, 27.8], use of a data safety-monitoring board (OR, 3.7; 95% CI: 1.2, 11.6), and VTE as the primary outcome (OR, 5.7; 95% CI: 1.7, 19.4) were associated with the use of an AC. Trials without random allocation concealment (OR, 0.3; 95% CI: 0.1, 0.8) and open-label trials (OR, 0.3; 95% CI: 0.1, 1.0) were less likely to report an AC. Recommended processes of adjudication are underreported and lack standardization in VTE-related clinical trials. The use of an AC varies substantially by trial characteristics. Copyright © 2014 Elsevier Inc. All rights reserved.

Meta-analysis: protein and energy supplementation in older people.

PubMed

Milne, Anne C; Avenell, Alison; Potter, Jan

2006-01-03

Protein and energy undernutrition is common in older people, and further deterioration may occur during illness. To assess whether oral protein and energy supplementation improves clinical and nutritional outcomes for older people in the hospital, in an institution, or in the community. Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, HealthStar, CINAHL, BIOSIS, and CAB abstracts. The authors included English- and non-English-language studies and hand-searched journals, contacted manufacturers, and sought information from trialists. The date of the most recent search of CENTRAL and MEDLINE is June 2005. Randomized and quasi-randomized controlled trials of oral protein and energy supplementation compared with placebo or control treatment in older people. Two reviewers independently assessed trials for inclusion, extracted data, and assessed trial quality. Differences were resolved by consensus. Fifty-five trials were included (n = 9187 randomly assigned participants). For patients in short-term care hospitals who were given oral supplements, evidence suggested fewer complications (Peto odds ratio, 0.72 [95% CI, 0.53 to 0.97]) and reduced mortality (Peto odds ratio, 0.66 [CI, 0.49 to 0.90]) for those undernourished at baseline. Few studies reported evidence that suggested any change in mortality, morbidity, or function for those given supplements at home. Ten trials reported gastrointestinal disturbances, such as nausea, vomiting, and diarrhea, with oral supplements. The quality of most studies, as reported, was poor, particularly for concealment of allocation and blinding of outcome assessors. Many studies were too small or the follow-up time was too short to detect a statistically significant change in clinical outcome. The clinical results are dominated by 1 very large recent trial in patients with stroke. Although this was a high-quality trial, few participants were undernourished at baseline. Oral nutritional supplements can improve nutritional status and seem to reduce mortality and complications for undernourished elderly patients in the hospital. Current evidence does not support routine supplementation for older people at home or for well-nourished older patients in any setting.

A State-of-the-Science Overview of Randomized Controlled Trials Evaluating Acute Management of Moderate-to-Severe Traumatic Brain Injury

PubMed Central

Synnot, Anneliese; Maas, Andrew I.; Menon, David K.; Cooper, D. James; Rosenfeld, Jeffrey V.; Gruen, Russell L.

2016-01-01

Abstract Moderate-to-severe traumatic brain injury (TBI) remains a major global challenge, with rising incidence, unchanging mortality and lifelong impairments. State-of-the-science reviews are important for research planning and clinical decision support. This review aimed to identify randomized controlled trials (RCTs) evaluating interventions for acute management of moderate/severe TBI, synthesize key RCT characteristics and findings, and determine their implications on clinical practice and future research. RCTs were identified through comprehensive database and other searches. Key characteristics, outcomes, risk of bias, and analysis approach were extracted. Data were narratively synthesized, with a focus on robust (multi-center, low risk of bias, n > 100) RCTs, and three-dimensional graphical figures also were used to explore relationships between RCT characteristics and findings. A total of 207 RCTs were identified. The 191 completed RCTs enrolled 35,340 participants (median, 66). Most (72%) were single center and enrolled less than 100 participants (69%). There were 26 robust RCTs across 18 different interventions. For 74% of 392 comparisons across all included RCTs, there was no significant difference between groups. Positive findings were broadly distributed with respect to RCT characteristics. Less than one-third of RCTs demonstrated low risk of bias for random sequence generation or allocation concealment, less than one-quarter used covariate adjustment, and only 7% employed an ordinal analysis approach. Considerable investment of resources in producing 191 completed RCTs for acute TBI management has resulted in very little translatable evidence. This may result from broad distribution of research effort, small samples, preponderance of single-center RCTs, and methodological shortcomings. More sophisticated RCT design, large multi-center RCTs in priority areas, increased focus on pre-clinical research, and alternatives to RCTs, such as comparative effectiveness research and precision medicine, are needed to fully realize the potential of acute TBI research to benefit patients. PMID:26711675

Methodological review: quality of randomized controlled trials in health literacy.

PubMed

Brainard, Julii; Wilsher, Stephanie Howard; Salter, Charlotte; Loke, Yoon Kong

2016-07-11

The growing move towards patient-centred care has led to substantial research into improving the health literacy skills of patients and members of the public. Hence, there is a pressing need to assess the methodology used in contemporary randomized controlled trials (RCTs) of interventions directed at health literacy, in particular the quality (risk of bias), and the types of outcomes reported. We conducted a systematic database search for RCTs involving interventions directed at health literacy in adults, published from 2009 to 2014. The Cochrane Risk of Bias tool was used to assess quality of RCT implementation. We also checked the sample size calculation for primary outcomes. Reported evidence of efficacy (statistical significance) was extracted for intervention outcomes in any of three domains of effect: knowledge, behaviour, health status. Demographics of intervention participants were also extracted, including socioeconomic status. We found areas of methodological strength (good randomization and allocation concealment), but areas of weakness regarding blinding of participants, people delivering the intervention and outcomes assessors. Substantial attrition (losses by monitoring time point) was seen in a third of RCTs, potentially leading to insufficient power to obtain precise estimates of intervention effect on primary outcomes. Most RCTs showed that the health literacy interventions had some beneficial effect on knowledge outcomes, but this was typically for less than 3 months after intervention end. There were far fewer reports of significant improvements in substantive patient-oriented outcomes, such as beneficial effects on behavioural change or health (clinical) status. Most RCTs featured participants from vulnerable populations. Our evaluation shows that health literacy trial design, conduct and reporting could be considerably improved, particularly by reducing attrition and obtaining longer follow-up. More meaningful RCTs would also result if health literacy trials were designed with public and patient involvement to focus on clinically important patient-oriented outcomes, rather than just knowledge, behaviour or skills in isolation.

Oral vaccine (OM-89) in the recurrent urinary tract infection prophylaxis: a realistic systematic review with meta-analysis.

PubMed

Taha Neto, K A; Nogueira Castilho, L; Reis, L O

2016-05-01

To evaluate the efficacy of Escherichia Coli extract (OM-89) in the prophylaxis of recurrent uncomplicated urinary tract infection (UTI) through a contemporary systematic review and meta-analysis. Inclusion criteria were double-blind randomized trials using orally administrated OM-89, 6mg daily, during three months with a minimum of three months of monitoring. Outcomes were the frequency of bacteriuria in 3 and 6 months, dysuria in 6 months and UTI in 6 months. PubMed, MEDLINE, Cochrane Collaboration and their key references. After analysis by three independent reviewers, 15 double-blind randomized trials were identified, 10 papers excluded due to methods flaws and 5 used for data analysis due to double blinding and reporting drop-outs. Among 5 selected studies the date of publication ranged from 1985 to 2005, totalizing 396 patients in the OM-89 group and 392 in the control group. Overall, there were 61 dropouts in the control group and 76 in the OM-89 group. As a major limitation there was no appropriate description of their methodologies and none of the studies described conflict of interest or commitment to the pharmaceutical industry. All studies were multi-centric, except for two, which showed no clarity on allocation concealment. All studies show benefit in favor of vaccine. Current literature on prospective randomized controlled trials evaluating the use of oral OM-89 vaccine in the recurrent UTI prophylaxis is of low quality, limited to the first six months only and with variable definition of bacteriuria and UTI. Although all studies show benefit in favor of vaccine, no robust trial was identified, resulting in a high heterogeneity in the data analyzed. Also, publication bias could not be excluded and future higher quality studies are warranted adding intermediate (>12 months) and long-term follow-up. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Randomized controlled trials and neuro-oncology: should alternative designs be considered?

PubMed

Mansouri, Alireza; Shin, Samuel; Cooper, Benjamin; Srivastava, Archita; Bhandari, Mohit; Kondziolka, Douglas

2015-09-01

Deficiencies in design and reporting of randomized controlled trials (RCTs) hinders interpretability and critical appraisal. The reporting quality of recent RCTs in neuro-oncology was analyzed to assess adequacy of design and reporting. The MEDLINE and EMBASE databases were searched to identify non-surgical RCTs (years 2005-2014, inclusive). The CONSORT and Jadad scales were used to assess the quality of design/reporting. Studies published in 2005-2010 were compared as a cohort against studies published in 2011-2014, in terms of general characteristics and reporting quality. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman's test was used to assess correlations. Regression analysis was used to assess associations. Overall 68 RCTs were identified. Studies were often chemotherapy-based (n = 41 studies) focusing upon high grade gliomas (46 %) and metastases (41 %) as the top pathologies. Multi-center trials (71 %) were frequent. The overall median CONSORT and Jadad scores were 34.5 (maximum 44) and 2 (maximum 5), respectively; these scores were similar in radiation and chemotherapy-based trials. Major areas of deficiency pertained to allocation concealment, implementation of methods, and blinding whereby less than 20 % of articles fulfilled all criteria. Description of intervention, random sequence generation, and the details regarding recruitment were also deficient; less than 50 % of studies fulfilled all criteria. Description of sample size calculations and blinding improved in later published cohorts. Journal impact factor was significantly associated with higher quality (p = 0.04). Large academic consortia, multi-center designs, ITT analysis, collaboration with biostatisticians, larger sample sizes, and studies with pragmatic objectives were more likely to achieve positive primary outcomes on univariate analysis; none of these variables were significant on multivariate analysis. Deficiencies in the quality of design/reporting of RCTs in neuro-oncology persist. Quality improvement is necessary. Consideration of alternative strategies should be considered.

Critical appraisal of clinical trials in multiple system atrophy: Toward better quality.

PubMed

Castro Caldas, Ana; Levin, Johannes; Djaldetti, Ruth; Rascol, Olivier; Wenning, Gregor; Ferreira, Joaquim J

2017-10-01

Multiple system atrophy (MSA) is a rare neurodegenerative disease of undetermined cause. Although many clinical trials have been conducted, there is still no treatment that cures the disease or slows its progression. We sought to assess the clinical trials, methodology, and quality of reporting of clinical trails conducted in MSA patients. We conducted a systematic review of all trials with at least 1 MSA patient subject to any pharmacological/nonpharmacological interventions. Two independent reviewers evaluated the methodological characteristics and quality of reporting of trials. A total of 60 clinical trials were identified, including 1375 MSA patients. Of the trials, 51% (n = 31) were single-arm studies. A total of 28% (n = 17) had a parallel design, half of which (n = 13) were placebo controlled. Of the studies, 8 (13.3%) were conducted in a multicenter setting, 3 of which were responsible for 49.3% (n = 678) of the total included MSA patients. The description of primary outcomes was unclear in 60% (n = 40) of trials. Only 10 (16.7%) clinical trials clearly described the randomization process. Blinding of the participants, personnel, and outcome assessments were at high risk of bias in the majority of studies. The number of dropouts/withdrawals was high (n = 326, 23.4% among the included patients). Overall, the design and quality of reporting of the reviewed studies is unsatisfactory. The most frequent clinical trials were small and single centered. Inadequate reporting was related to the information on the randomization process, sequence generation, allocation concealment, blinding of participants, and sample size calculations. Although improved during the recent years, methodological quality and trial design need to be optimized to generate more informative results. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement Disorder Society.

Effects of diazoxide in multiple sclerosis

PubMed Central

Rovira, Alex; Montalban, Xavier; Arroyo, Rafael; Paul, Friedemann; Meca-Lallana, Virginia; Ramo, Cristina; Fernandez, Oscar; Saiz, Albert; Garcia-Merino, Antonio; Ramió-Torrentà, Lluís; Casanova, Bonaventura; Oreja-Guevara, Celia; Muñoz, Delicias; Martinez-Rodriguez, Jose Enrique; Lensch, Eckart; Prieto, Jose Maria; Meuth, Sven G.; Nuñez, Xavier; Campás, Clara; Pugliese, Marco

2015-01-01

Objective: The aim of this study was to test the safety of diazoxide and to search for signs of efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: In this multicenter, randomized, placebo-controlled, double-blind trial (treatment allocation was concealed), 102 patients with RRMS were randomized to receive a daily oral dose of diazoxide (0.3 and 4 mg/d) or placebo for 24 weeks (NCT01428726). The primary endpoint was the cumulative number of new T1 gadolinium-enhancing lesions per patient, recorded every 4 weeks from week 4 to week 24. Secondary endpoints included brain MRI variables such as the number of new/enlarging T2 lesions and the percentage brain volume change (PBVC); clinical variables such as the percentage of relapse-free patients, relapse rate, and change in the Expanded Disability Status Scale score; and safety and tolerability. Results: Diazoxide was well-tolerated and it produced no serious adverse events other than 1 case of Hashimoto disease. At the 2 doses tested, diazoxide did not improve the primary endpoint or the MRI and clinical variables related to the presence of new lesions or relapses. Patients treated with diazoxide showed reduced PBVC compared with the placebo group, although such changes could be confounded by the higher disease activity of the treated group and the vascular effects of diazoxide. Conclusion: At the doses tested, oral diazoxide did not decrease the appearance of new lesions evident by MRI. The effects in slowing the progression of brain atrophy require further validation. Classification of evidence: This study provides Class I evidence that for patients with RRMS, diazoxide (0.3 and 4 mg/d) does not significantly change the number of new MRI T1 gadolinium-enhancing lesions. PMID:26405686

Analysis of the Quality of Clinical Trials Published in Spanish-Language Dermatology Journals Between 1997 and 2012.

PubMed

Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

2016-01-01

The value of randomized clinical trials (RCTs) undertaken to identify an association between an intervention and an outcome is determined by their quality and scientific rigor. To assess the methodological quality of RCTs published in Spanish-language dermatology journals. By way of a systematic manual search, we identified all the RCTs in journals published in Spain and Latin America between 1997 (the year in which the CONSORT statement was published) and 2012. Risk of bias was evaluated for each RCT by assessing the following domains: randomization sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up. Source of funding and conflict of interest statements, if any, were recorded for each study. The search identified 70 RCTs published in 21 journals. Most of the RCTs had a high risk of bias, primarily because of gaps in the reporting of important methodological aspects. The source of funding was reported in only 15 studies. In spite of the considerable number of Spanish and Latin American journals, few RCTs have been published in the 15 years analyzed. Most of the RCTs published had serious defects in that the authors omitted methodological information essential to any evaluation of the quality of the trial and failed to report sources of funding or possible conflicts of interest for the authors involved. Authors of experimental clinical research in dermatology published in Spain and Latin America need to substantially improve both the design of their trials and the reporting of results. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

Clinical trials in palliative care: a systematic review of their methodological characteristics and of the quality of their reporting.

PubMed

Bouça-Machado, Raquel; Rosário, Madalena; Alarcão, Joana; Correia-Guedes, Leonor; Abreu, Daisy; Ferreira, Joaquim J

2017-01-25

Over the past decades there has been a significant increase in the number of published clinical trials in palliative care. However, empirical evidence suggests that there are methodological problems in the design and conduct of studies, which raises questions about the validity and generalisability of the results and of the strength of the available evidence. We sought to evaluate the methodological characteristics and assess the quality of reporting of clinical trials in palliative care. We performed a systematic review of published clinical trials assessing therapeutic interventions in palliative care. Trials were identified using MEDLINE (from its inception to February 2015). We assessed methodological characteristics and describe the quality of reporting using the Cochrane Risk of Bias tool. We retrieved 107 studies. The most common medical field studied was oncology, and 43.9% of trials evaluated pharmacological interventions. Symptom control and physical dimensions (e.g. intervention on pain, breathlessness, nausea) were the palliative care-specific issues most studied. We found under-reporting of key information in particular on random sequence generation, allocation concealment, and blinding. While the number of clinical trials in palliative care has increased over time, methodological quality remains suboptimal. This compromises the quality of studies. Therefore, a greater effort is needed to enable the appropriate performance of future studies and increase the robustness of evidence-based medicine in this important field.

Therapeutic play to prepare children for invasive procedures: a systematic review.

PubMed

Silva, Rosalia Daniela Medeiros da; Austregésilo, Silvia Carréra; Ithamar, Lucas; Lima, Luciane Soares de

To analyze the available evidence regarding the efficacy of using therapeutic play on behavior and anxiety in children undergoing invasive procedures. The systematic review search was performed in the MEDLINE, LILACS, CENTRAL and CINAHL databases. There was no limitation on the year or language. The literature search found 1892 articles and selected 22 for full reading. Eight articles were excluded, as they did not address the objectives assessed in this review. Twelve studies, representing 14 articles, were included. The studies were conducted between 1983 and 2015, five in Brazil, one in the United States, five in China, one in Lebanon, one in Taiwan, and one in Iran. Most studies showed that intervention with therapeutic play promotes reduction in the level of anxiety and promotes collaborative behavior and acceptance of the invasive procedure. Evidence related to the use of therapeutic play on anxiety and behavior of children undergoing invasive procedures is still questionable. The absence, in most studies, of the creation of a random sequence to assign the subjects to either the control or the experimental group, as well as allocation concealment, are factors that contribute to these questions. Another issue that characterizes an important source of bias is the absence of blinded evaluators. It is necessary to perform further studies that will take into account greater methodological stringency. Copyright © 2016 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

Surgical interventions for gastric cancer: a review of systematic reviews.

PubMed

He, Weiling; Tu, Jian; Huo, Zijun; Li, Yuhuang; Peng, Jintao; Qiu, Zhenwen; Luo, Dandong; Ke, Zunfu; Chen, Xinlin

2015-01-01

To evaluate methodological quality and the extent of concordance among meta-analysis and/or systematic reviews on surgical interventions for gastric cancer (GC). A comprehensive search of PubMed, Medline, EMBASE, the Cochrane library and the DARE database was conducted to identify the reviews comparing different surgical interventions for GC prior to April 2014. After applying included criteria, available data were summarized and appraised by the Oxman and Guyatt scale. Fifty six reviews were included. Forty five reviews (80.4%) were well conducted, with scores of adapted Oxman and Guyatt scale ≥ 14. The reviews differed in criteria for avoiding bias and assessing the validity of the primary studies. Many primary studies displayed major methodological flaws, such as randomization, allocation concealment, and dropouts and withdrawals. According to the concordance assessment, laparoscopy-assisted gastrectomy (LAG) was superior to open gastrectomy, and laparoscopy-assisted distal gastrectomy was superior to open distal gastrectomy in short-term outcomes. However, the concordance regarding other surgical interventions, such as D1 vs. D2 lymphadenectomy, and robotic gastrectomy vs. LAG were absent. Systematic reviews on surgical interventions for GC displayed relatively high methodological quality. The improvement of methodological quality and reporting was necessary for primary studies. The superiority of laparoscopic over open surgery was demonstrated. But concordance on other surgical interventions was rare, which needed more well-designed RCTs and systematic reviews.

An Overview of Randomization and Minimization Programs for Randomized Clinical Trials

PubMed Central

Saghaei, Mahmoud

2011-01-01

Randomization is an essential component of sound clinical trials, which prevents selection biases and helps in blinding the allocations. Randomization is a process by which subsequent subjects are enrolled into trial groups only by chance, which essentially eliminates selection biases. A serious consequence of randomization is severe imbalance among the treatment groups with respect to some prognostic factors, which invalidate the trial results or necessitate complex and usually unreliable secondary analysis to eradicate the source of imbalances. Minimization on the other hand tends to allocate in such a way as to minimize the differences among groups, with respect to prognostic factors. Pure minimization is therefore completely deterministic, that is, one can predict the allocation of the next subject by knowing the factor levels of a previously enrolled subject and having the properties of the next subject. To eliminate the predictability of randomization, it is necessary to include some elements of randomness in the minimization algorithms. In this article brief descriptions of randomization and minimization are presented followed by introducing selected randomization and minimization programs. PMID:22606659

Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis

PubMed Central

Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

2017-01-01

Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Conclusions Studies evaluating CHM often fail to meet expected methodological criteria, and high-quality evidence is lacking. PMID:28249848

Endorsement of the CONSORT guidelines, trial registration, and the quality of reporting randomised controlled trials in leading nursing journals: A cross-sectional analysis.

PubMed

Jull, Andrew; Aye, Phyu Sin

2015-06-01

To establish the reporting quality of trials published in leading nursing journals and investigate associations between CONSORT Statement or trial registration endorsment and reporting of design elements. The top 15 nursing journals were searched using Medline for randomised controlled trials published in 2012. Journals were categorised as CONSORT and trial registration promoting based on requirements of submitting authors or the journal's webpage as at January 2014. Data on sequence generation, allocation concealment, follow up, blinding, baseline equivalence and sample size calculation were extracted by one author and independently verified by the second author against source data. Seven journals were CONSORT promoting and three of these journals were also trial registration promoting. 114 citations were identified and 83 were randomised controlled trials. Eighteen trials (21.7%) were registered and those published in trial registration promoting journals were more likely to be registered (RR 2.64 95%CI 1.14-6.09). We assessed 68.7% of trials to be low risk of bias for sequence generation, 20.5% for allocation concealment, 38.6% for blinding, 55.4% for completeness of follow up and 79.5% for baseline equivalence. Trials published in CONSORT promoting journals were more likely to be at low risk of bias for blinding (RR 2.33, 95%CI 1.01-5.34) and completeness of follow up (RR 1.77, 95%CI 1.02-3.10), but journal endorsement of the CONSORT Statement or trial registration otherwise had no significant effect. Trials published in CONSORT and trial registration promoting journals were more likely to have high quality sample size calculations (RR 2.91, 95%CI 1.18-7.19 and RR 1.69, 95%CI 1.08-2.64, respectively). Simple endorsement of the CONSORT Statement and trials registration is insufficient action to encourage improvement of the quality of trial reporting across the most important of trial design elements. Copyright © 2014 Elsevier Ltd. All rights reserved.

Internet-based implementation of non-pharmacological interventions of the "people getting a grip on arthritis" educational program: an international online knowledge translation randomized controlled trial design protocol.

PubMed

Brosseau, Lucie; Wells, George; Brooks-Lineker, Sydney; Bennell, Kim; Sherrington, Cathie; Briggs, Andrew; Sturnieks, Daina; King, Judy; Thomas, Roanne; Egan, Mary; Loew, Laurianne; De Angelis, Gino; Casimiro, Lynn; Toupin April, Karine; Cavallo, Sabrina; Bell, Mary; Ahmed, Rukhsana; Coyle, Doug; Poitras, Stéphane; Smith, Christine; Pugh, Arlanna; Rahman, Prinon

2015-02-03

Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers' Associations to participate using online recruitment. This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to "closed", thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8).

Internet-Based Implementation of Non-Pharmacological Interventions of the "People Getting a Grip on Arthritis" Educational Program: An International Online Knowledge Translation Randomized Controlled Trial Design Protocol

PubMed Central

Thomas, Roanne; De Angelis, Gino

2015-01-01

Background Rheumatoid arthritis (RA) affects 2.1% of the Australian population (1.5% males; 2.6% females), with the highest prevalence from ages 55 to over 75 years (4.4-6.1%). In Canada, RA affects approximately 0.9% of adults, and within 30 years that is expected to increase to 1.3%. With an aging population and a greater number of individuals with modifiable risk factors for chronic diseases, such as arthritis, there is an urgent need for co-care management of arthritic conditions. The increasing trend and present shifts in the health services and policy sectors suggest that digital information delivery is becoming more prominent. Therefore, it is necessary to further investigate the use of online resources for RA information delivery. Objective The objective is to examine the effect of implementing an online program provided to patients with RA, the People Getting a Grip on Arthritis for RA (PGrip-RA) program, using information communication technologies (ie, Facebook and emails) in combination with arthritis health care professional support and electronic educational pamphlets. We believe this can serve as a useful and economical method of knowledge translation (KT). Methods This KT randomized controlled trial will use a prospective randomized open-label blinded-endpoint design to compare four different intervention approaches of the PGrip-RA program to a control group receiving general electronic educational pamphlets self-management in RA via email. Depending on group allocation, links to the Arthritis Society PGrip-RA material will be provided either through Facebook or by email. One group will receive feedback online from trained health care professionals. The intervention period is 6 weeks. Participants will have access to the Internet-based material after the completion of the baseline questionnaires until the final follow-up questionnaire at 6 months. We will invite 396 patients from Canadian and Australian Arthritis Consumers’ Associations to participate using online recruitment. Results This study will build on a pilot study using Facebook, which revealed promising effects of knowledge acquisition/integration of the evidence-based self-management PGrip educational program. Conclusions The use of online techniques to disseminate knowledge provides an opportunity to reduce health care costs by facilitating self-management of people with arthritis. Study design strengths include the incorporation of randomization and allocation concealment to ensure internal validity. To avoid intergroup contamination, the Facebook group page security settings will be set to “closed”, thus allowing only invited participants to access it. Study limitations include the lack of participant blinding due to the characteristics of this KT randomized controlled trial and a potential bias of recruiting patients only online, though this was proven effective in the previous pilot study. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12614000397617; http://www.anzctr.org.au/TrialSearch.aspx (Archived by WebCite at http://www.webcitation.org/6PrP0kQf8). PMID:25648515

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

PubMed

Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

2013-01-11

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. www.ClinicalTrials.gov Identifier: NCT00871715

Shoulder function and work disability after decompression surgery for subacromial impingement syndrome: a randomised controlled trial of physiotherapy exercises and occupational medical assistance

PubMed Central

2014-01-01

Background Surgery for subacromial impingement syndrome is often performed in working age and postoperative physiotherapy exercises are widely used to help restore function. A recent Danish study showed that 10% of a nationwide cohort of patients retired prematurely within two years after surgery. Few studies have compared effects of different postoperative exercise programmes on shoulder function, and no studies have evaluated workplace-oriented interventions to reduce postoperative work disability. This study aims to evaluate the effectiveness of physiotherapy exercises and occupational medical assistance compared with usual care in improving shoulder function and reducing postoperative work disability after arthroscopic subacromial decompression. Methods/Design The study is a mainly pragmatic multicentre randomised controlled trial. The trial is embedded in a cohort study of shoulder patients referred to public departments of orthopaedic surgery in Central Denmark Region. Patients aged ≥18–≤63 years, who still have shoulder symptoms 8–12 weeks after surgery, constitute the study population. Around 130 participants are allocated to: 1) physiotherapy exercises, 2) occupational medical assistance, 3) physiotherapy exercises and occupational medical assistance, and 4) usual care. Intervention manuals allow individual tailoring. Primary outcome measures include Oxford Shoulder Score and sickness absence due to symptoms from the operated shoulder. Randomisation is computerised with allocation concealment by randomly permuted block sizes. Statistical analyses will primarily be performed according to the intention-to-treat principle. Discussion The paper presents the rationale, design, methods, and operational aspects of the Shoulder Intervention Project (SIP). SIP evaluates a new rehabilitation approach, where physiotherapy and occupational interventions are provided in continuity of surgical episodes of care. If successful, the project may serve as a model for rehabilitation of surgical shoulder patients. Trial registration Current Controlled Trials ISRCTN55768749. PMID:24952581

Development and Evaluation of a Pedagogical Tool to Improve Understanding of a Quality Checklist: A Randomised Controlled Trial

PubMed Central

Fourcade, Lola; Boutron, Isabelle; Moher, David; Ronceray, Lucie; Baron, Gabriel; Ravaud, Philippe

2007-01-01

Objective: The aim of this study was to develop and evaluate a pedagogical tool to enhance the understanding of a checklist that evaluates reports of nonpharmacological trials (CLEAR NPT). Design: Paired randomised controlled trial. Participants: Clinicians and systematic reviewers. Interventions: We developed an Internet-based computer learning system (ICLS). This pedagogical tool used many examples from published randomised controlled trials to demonstrate the main coding difficulties encountered when using this checklist. Randomised participants received either a specific Web-based training with the ICLS (intervention group) or no specific training. Outcome measures: The primary outcome was the rate of correct answers compared to a criterion standard for coding a report of randomised controlled trials with the CLEAR NPT. Results: Between April and June 2006, 78 participants were randomly assigned to receive training with the ICLS (39) or no training (39). Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT. The mean paired difference and corresponding 95% confidence interval was 0.5 (−5.1 to 6.1). The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item. Combining both groups, the rate of correct answers was high or items related to allocation sequence (79.5%), description of the intervention (82.0%), blinding of patients (79.5%), and follow-up schedule (83.3%). The rate of correct answers was low for items related to allocation concealment (46.1%), co-interventions (30.3%), blinding of outcome assessors (53.8%), specific measures to avoid ascertainment bias (28.6%), and intention-to-treat analysis (60.2%). Conclusions: Although we showed no difference in effect between the intervention and control groups, our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct. PMID:17479163

Effect of Baduanjin exercise on cognitive function in patients with post-stroke cognitive impairment: study protocol for a randomised controlled trial.

PubMed

Zheng, Guohua; Zheng, Yuhui; Xiong, Zhenyu; Ye, Bingzhao; Tao, Jing; Chen, Lidian

2018-06-22

Poststroke cognitive impairment is one of the most common complications in stroke survivors, and >65% of these patients suffer from cognitive impairment at 12 months following onset, which strongly affects the rehabilitation of their motor function and quality of life. Therefore, it is important to improve the cognitive ability of stroke survivors. As an important component of traditional Chinese Qigong exercises, characterised by the coordination of mind and body with a low exercise intensity, Baduanjin has the potential benefit of improving cognitive ability for patients who had a stroke with cognitive impairment. The primary purpose of this study is to investigate the effectiveness and safety of Baduanjin training on the cognitive function of stroke survivors. This study is designed as a randomised, two-arm parallel controlled trial with allocation concealment and assessors blinding. A total of 48 participants will be recruited and randomly allocated into the Baduanjin exercise intervention or control group. Baduanjin intervention will last 24 weeks with a frequency of 3 days a week and 40 min a day. Global cognitive function and the specific domains of cognition (ie, memory, processing speed, execution, attention and visuospatial ability) will be measured at baseline, 8, 16 and, 24 weeks after intervention and after an additional 4-week follow-up period, while the motor function and quality of life will be measured at baseline, 24 weeks after intervention and after an additional 4-week follow-up period. Ethics approval was obtained from the Ethics Committee of Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital (approval number: 2016KY-022-01). The findings will be disseminated through peer-reviewed publications and at scientific conferences. ChiCTR-INR-16009364; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Lay public's understanding of equipoise and randomisation in randomised controlled trials.

PubMed

Robinson, E J; Kerr, C E P; Stevens, A J; Lilford, R J; Braunholtz, D A; Edwards, S J; Beck, S R; Rowley, M G

2005-03-01

To research the lay public's understanding of equipoise and randomisation in randomised controlled trials (RCTs) and to look at why information on this may not be not taken in or remembered, as well as the effects of providing information designed to overcome barriers. Investigations were informed by an update of systematic review on patients' understanding of consent information in clinical trials, and by relevant theory and evidence from experimental psychology. Nine investigations were conducted with nine participants. Access (return to education), leisure and vocational courses at Further Education Colleges in the Midlands, UK. Healthy adults with a wide range of educational backgrounds and ages. Participants read hypothetical scenarios and wrote brief answers to subsequent questions. Sub-samples of participants were interviewed individually to elaborate on their written answers. Participants' background assumptions concerning equipoise and randomisation were examined and ways of helping participants recognise the scientific benefits of randomisation were explored. Judgments on allocation methods; treatment preferences; the acceptability of random allocation; whether or not individual doctors could be completely unsure about the best treatment; whether or not doctors should reveal treatment preferences under conditions of collective equipoise; and how sure experts would be about the best treatment following random allocation vs doctor/patient choice. Assessments of understanding hypothetical trial information. Recent literature continues to report trial participants' failure to understand or remember information about randomisation and equipoise, despite the provision of clear and readable trial information leaflets. In current best practice, written trial information describes what will happen without offering accessible explanations. As a consequence, patients may create their own incorrect interpretations and consent or refusal may be inadequately informed. In six investigations, most participants identified which methods of allocation were random, but judged the random allocation methods to be unacceptable in a trial context; the mere description of a treatment as new was insufficient to engender a preference for it over a standard treatment; around half of the participants denied that a doctor could be completely unsure about the best treatment. A majority of participants judged it unacceptable for a doctor to suggest letting chance decide when uncertain of the best treatment, and, in the absence of a justification for random allocation, participants did not recognise scientific benefits of random allocation over normal treatment allocation methods. The pattern of results across three intervention studies suggests that merely supplementing written trial information with an explanation is unlikely to be helpful. However, when people manage to focus on the trial's aim of increasing knowledge (as opposed to making treatment decisions about individuals), and process an explanation actively, they may be helped to understand the scientific reasons for random allocation. This research was not carried out in real healthcare settings. However, participants who could correctly identify random allocation methods, yet judged random allocation unacceptable, doubted the possibility of individual equipoise and saw no scientific benefits of random allocation over doctor/patient choice, are unlikely to draw upon contrasting views if invited to enter a real clinical trial. This suggests that many potential trial participants may have difficulty understanding and remembering trial information that conforms to current best practice in its descriptions of randomisation and equipoise. Given the extent of the disparity between the assumptions underlying trial design and the assumptions held by the lay public, the solution is unlikely to be simple. Nevertheless, the results suggest that including an accessible explanation of the scientific benefits of randomisation may be beneficial provided potential participants are also enabled to reflect on the trial's aim of advancing knowledge, and to think actively about the information presented. Further areas for consideration include: the identification of effective combinations of written and oral information; helping participants to reflect on the aim of advancing knowledge; and an evidence-based approach to leaflet construction.

The nest-concealment hypothesis: New insights from a comparative analysis

USGS Publications Warehouse

Borgmann, Kathi L.; Conway, Courtney J.

2015-01-01

Selection of a breeding site is critical for many animals, especially for birds whose offspring are stationary during development. Thus, birds are often assumed to prefer concealed nest sites. However, 74% of studies (n = 106) that have evaluated this relationship for open-cup nesting songbirds in North America failed to support the nest-concealment hypothesis. We conducted a comparative analysis to identify factors that contribute to variation in the ability of researchers to find support for the nest-concealment hypothesis. We found that some of the discrepancy among studies can be explained by interspecific differences in morphological and extrinsic factors that affect nest predation. Moreover, methods that investigators used to estimate concealment affected whether studies found support for the nest-concealment hypothesis; 33% of the studies that used quantitative estimates found support for the nest-concealment hypothesis whereas only 10% of the studies that used qualitative estimates found support. The timing of measurements also explained some of the ambiguity; studies that provided little information regarding the timing of their foliage density estimates were less likely to support the nest-concealment hypothesis. Species with more conspicuous male plumage were less likely to support the nest-concealment hypothesis when we analyzed studies that used visual estimates. Whereas species with more conspicuous female plumage were more likely to support the nest-concealment hypothesis when we analyzed studies that used quantitative measures. Our results demonstrate that support for the nest-concealment hypothesis has been equivocal, but that some of the ambiguity can be explained by morphological traits and methods used to measure concealment.

Low level laser therapy and hair regrowth: an evidence-based review.

PubMed

Zarei, Mina; Wikramanayake, Tongyu C; Falto-Aizpurua, Leyre; Schachner, Lawrence A; Jimenez, Joaquin J

2016-02-01

Despite the current treatment options for different types of alopecia, there is a need for more effective management options. Recently, low-level laser therapy (LLLT) was evaluated for stimulating hair growth. Here, we reviewed the current evidence on the LLLT effects with an evidence-based approach, focusing more on randomized controlled studies by critically evaluating them. In order to investigate whether in individuals presenting with hair loss (male pattern hair loss (MPHL), female pattern hair loss (FPHL), alopecia areata (AA), and chemotherapy-induced alopecia (CIA)) LLLT is effective for hair regrowth, several databases including PubMed, Google Scholar, Medline, Embase, and Cochrane Database were searched using the following keywords: Alopecia, Hair loss, Hair growth, Low level laser therapy, Low level light therapy, Low energy laser irradiation, and Photobiomodulation. From the searches, 21 relevant studies were summarized in this review including 2 in vitro, 7 animal, and 12 clinical studies. Among clinical studies, only five were randomized controlled trials (RCTs), which evaluated LLLT effect on male and female pattern hair loss. The RCTs were critically appraised using the created checklist according to the Critical Appraisal for Therapy Articles Worksheet created by the Center of Evidence-Based Medicine, Oxford. The results demonstrated that all the performed RCTs have moderate to high quality of evidence. However, only one out of five studies performed intention-to-treat analysis, and only another study reported the method of randomization and subsequent concealment of allocation clearly; all other studies did not include this very important information in their reports. None of these studies reported the treatment effect of factors such as number needed to treat. Based on this review on all the available evidence about effect of LLLT in alopecia, we found that the FDA-cleared LLLT devices are both safe and effective in patients with MPHL and FPHL who did not respond or were not tolerant to standard treatments. Future randomized controlled trials of LLLT are strongly encouraged to be conducted and reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement to facilitate analysis and comparison.

Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

PubMed

Ruzagira, Eugene; Grosskurth, Heiner; Kamali, Anatoli; Baisley, Kathy

2017-10-01

The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial.

PubMed

Hartling, Lisa; Newton, Amanda S; Liang, Yuanyuan; Jou, Hsing; Hewson, Krista; Klassen, Terry P; Curtis, Sarah

2013-09-01

Many medical procedures aimed at helping children cause them pain and distress, which can have long-lasting negative effects. Music is a form of distraction that may alleviate some of the pain and distress experienced by children while undergoing medical procedures. To compare music with standard care to manage pain and distress. Randomized clinical trial conducted in a pediatric emergency department with appropriate sequence generation and adequate allocation concealment from January 1, 2009, to March 31, 2010. Individuals assessing the primary outcome were blind to treatment allocation. A total of 42 children aged 3 to 11 years undergoing intravenous placement were included. Music (recordings selected by a music therapist via ambient speakers) vs standard care. The primary outcome was behavioral distress assessed blinded using the Observational Scale of Behavioral Distress-Revised. The secondary outcomes included child-reported pain, heart rate, parent and health care provider satisfaction, ease of performing the procedure, and parental anxiety. With or without controlling for potential confounders, we found no significant difference in the change in behavioral distress from before the procedure to immediately after the procedure. When children who had no distress during the procedure were removed from the analysis, there was a significantly less increase in distress for the music group (standard care group = 2.2 vs music group = 1.1, P < .05). Pain scores among children in the standard care group increased by 2 points, while they remained the same in the music group (P = .04); the difference was considered clinically important. The pattern of parent satisfaction with the management of children's pain was different between groups, although not statistically significant (P = .07). Health care providers reported that it was easier to perform the procedure for children in the music group (76% very easy) vs the standard care group (38% very easy) (P = .03). Health care providers were more satisfied with the intravenous placement in the music group (86% very satisfied) compared with the standard care group (48%) (P = .02). Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers. clinicaltrials.gov Identifier: NCT00761033.

Relationship between concealment of emotions at work and musculoskeletal symptoms: results from the third Korean Working Conditions Survey.

PubMed

Jung, Kyungyong; Kim, Dae Hwan; Ryu, Ji Young

2018-05-11

In this study, we explored the relationship between concealing emotions at work and musculoskeletal symptoms in Korean workers using data from a national, population-based survey. Data were obtained from the third Korean Working Conditions Survey in 2011. We investigated the prevalence of three musculoskeletal symptoms ("back pain", "pain in the upper extremities", and "pain in the lower extremities"). Multiple logistic regression analysis was also performed to determine odds ratios (ORs) for musculoskeletal symptoms according to concealing emotions at work, adjusting for socioeconomic factors. In both sexes, the emotion-concealing group showed a significantly higher prevalence of "pain in the upper extremities" and "pain in the lower extremities" than the non-emotion-concealing group. For back pain, male - but not female - workers who concealed their emotions showed a higher prevalence than their non-emotion-concealing counterparts; the difference was statistically significant. Adjusted ORs for musculoskeletal symptoms (excluding "back pain" for female workers) in the emotion-concealing group were significantly higher. Our study suggests that concealment of emotions is closely associated with musculoskeletal symptoms, and the work environment should operate in consideration not only of the physical health work condition of workers but also of their emotional efforts including concealing emotion at work.

Cars, CONSORT 2010, and clinical practice.

PubMed

Williams, Hywel C

2010-03-24

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the updated CONSORT 2010 statement enables the reader to see exactly what was done in a trial, to whom and when. A fully "CONSORTed" trial report does not necessarily mean the trial is a good one, but at least the reader can make a judgement. Clear reporting is a pre-requisite for judgement of study quality. The CONSORT statement evolves as empirical research moves on. CONSORT 2010 is even clearer than before and includes some new items with a particular emphasis on selective reporting of outcomes. The challenge is for everyone to use it.

An Exploratory Investigation of Social Stigma and Concealment in Patients with Multiple Sclerosis.

PubMed

Cook, Jonathan E; Germano, Adriana L; Stadler, Gertraud

2016-01-01

We conducted a preliminary investigation into dimensions of stigma and their relation to disease concealment in a sample of American adults living with multiple sclerosis (MS). Fifty-three adults with MS in the United States completed an online survey assessing anticipated, internalized, and isolation stigma, as well as concealment. Responses to all the scales were relatively low, on average, but above scale minimums (P < .001). Ratings of isolation stigma and concealment were highest. Anticipated stigma strongly predicted concealment. Many adults living with MS may be concerned that they will be the target of social stigma because of their illness. These concerns are associated with disease concealment. More research is needed to investigate how MS stigma and concealment may be independent contributors to health in patients with MS.

Concealment of sexual orientation.

PubMed

Sylva, David; Rieger, Gerulf; Linsenmeier, Joan A W; Bailey, J Michael

2010-02-01

Sex-atypical behaviors may be used to identify a person as homosexual. To shield themselves from prejudice, homosexual people may attempt to conceal these behaviors. It is not clear how effectively they can do so. In Study 1, we asked homosexual participants to conceal their sex-atypical behaviors while talking about the weather. Raters watched videos of the participants and judged the likelihood that each participant was homosexual. Homosexual participants were able to partially conceal signs of their orientation, but they remained distinguishable from heterosexual participants. In Study 2, we tested the ability to conceal signs of one's sexual orientation in a more demanding situation: a mock job interview. In this scenario, homosexual men were even less effective at concealing their orientation. Higher cognitive demands in this new situation may have interfered with their ability to conceal.

Student attitudes toward concealed handguns on campus at 2 universities.

PubMed

Cavanaugh, Michael R; Bouffard, Jeffrey A; Wells, William; Nobles, Matt R

2012-12-01

We examined student support for a policy that would allow carrying of concealed handguns on university campuses. Large percentages of students at 2 universities expressed very low levels of comfort with the idea of permitting concealed handgun carrying on campus, suggesting that students may not welcome less restrictive policies. Students held slightly different opinions about concealed handguns on and off campus, suggesting that they view the campus environment as unique with respect to concealed handgun carrying.

Variability in Parameter Estimates and Model Fit across Repeated Allocations of Items to Parcels

ERIC Educational Resources Information Center

Sterba, Sonya K.; MacCallum, Robert C.

2010-01-01

Different random or purposive allocations of items to parcels within a single sample are thought not to alter structural parameter estimates as long as items are unidimensional and congeneric. If, additionally, numbers of items per parcel and parcels per factor are held fixed across allocations, different allocations of items to parcels within a…

Student Attitudes Toward Concealed Handguns on Campus at 2 Universities

PubMed Central

Bouffard, Jeffrey A.; Wells, William; Nobles, Matt R.

2012-01-01

We examined student support for a policy that would allow carrying of concealed handguns on university campuses. Large percentages of students at 2 universities expressed very low levels of comfort with the idea of permitting concealed handgun carrying on campus, suggesting that students may not welcome less restrictive policies. Students held slightly different opinions about concealed handguns on and off campus, suggesting that they view the campus environment as unique with respect to concealed handgun carrying. PMID:22720763

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

Concealing Concealment: The Mediating Role of Internalized Heterosexism in Psychological Distress Among Lesbian, Gay, and Bisexual Older Adults

PubMed Central

Hoy-Ellis, Charles P.

2016-01-01

Recent population-based studies indicate that sexual minorities aged 50 and older experience significantly higher rates of psychological distress than their heterosexual age-peers. The minority stress model has been useful in explaining disparately high rates of psychological distress among younger sexual minorities. The purpose of this study is to test a hypothesized structural relationship between two minority stressors—internalized heterosexism and concealment of sexual orientation—and consequent psychological distress among a sample of 2,349 lesbian, gay, and bisexual adults aged 50 to 95 years old. Structural equation modeling indicates that concealment has a nonsignificant direct effect on psychological distress but a significant indirect effect that is mediated through internalized heterosexism; the effect of concealment is itself concealed. This may explain divergent results regarding the role of concealment in psychological distress in other studies, and the implications will be discussed. PMID:26322654

Wavelet Fusion for Concealed Object Detection Using Passive Millimeter Wave Sequence Images

NASA Astrophysics Data System (ADS)

Chen, Y.; Pang, L.; Liu, H.; Xu, X.

2018-04-01

PMMW imaging system can create interpretable imagery on the objects concealed under clothing, which gives the great advantage to the security check system. Paper addresses wavelet fusion to detect concealed objects using passive millimeter wave (PMMW) sequence images. According to PMMW real-time imager acquired image characteristics and storage methods firstly, using the sum of squared difference (SSD) as the image-related parameters to screen the sequence images. Secondly, the selected images are optimized using wavelet fusion algorithm. Finally, the concealed objects are detected by mean filter, threshold segmentation and edge detection. The experimental results show that this method improves the detection effect of concealed objects by selecting the most relevant images from PMMW sequence images and using wavelet fusion to enhance the information of the concealed objects. The method can be effectively applied to human body concealed object detection in millimeter wave video.

Classification-Based Spatial Error Concealment for Visual Communications

NASA Astrophysics Data System (ADS)

Chen, Meng; Zheng, Yefeng; Wu, Min

2006-12-01

In an error-prone transmission environment, error concealment is an effective technique to reconstruct the damaged visual content. Due to large variations of image characteristics, different concealment approaches are necessary to accommodate the different nature of the lost image content. In this paper, we address this issue and propose using classification to integrate the state-of-the-art error concealment techniques. The proposed approach takes advantage of multiple concealment algorithms and adaptively selects the suitable algorithm for each damaged image area. With growing awareness that the design of sender and receiver systems should be jointly considered for efficient and reliable multimedia communications, we proposed a set of classification-based block concealment schemes, including receiver-side classification, sender-side attachment, and sender-side embedding. Our experimental results provide extensive performance comparisons and demonstrate that the proposed classification-based error concealment approaches outperform the conventional approaches.

25 CFR 11.444 - Carrying concealed weapons.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Carrying concealed weapons. 11.444 Section 11.444 Indians... ORDER CODE Criminal Offenses § 11.444 Carrying concealed weapons. A person who goes about in public places armed with a dangerous weapon concealed upon his or her person is guilty of a misdemeanor unless...

25 CFR 11.444 - Carrying concealed weapons.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 25 Indians 1 2013-04-01 2013-04-01 false Carrying concealed weapons. 11.444 Section 11.444 Indians... ORDER CODE Criminal Offenses § 11.444 Carrying concealed weapons. A person who goes about in public places armed with a dangerous weapon concealed upon his or her person is guilty of a misdemeanor unless...

25 CFR 11.444 - Carrying concealed weapons.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Carrying concealed weapons. 11.444 Section 11.444 Indians... ORDER CODE Criminal Offenses § 11.444 Carrying concealed weapons. A person who goes about in public places armed with a dangerous weapon concealed upon his or her person is guilty of a misdemeanor unless...

25 CFR 11.444 - Carrying concealed weapons.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Carrying concealed weapons. 11.444 Section 11.444 Indians... ORDER CODE Criminal Offenses § 11.444 Carrying concealed weapons. A person who goes about in public places armed with a dangerous weapon concealed upon his or her person is guilty of a misdemeanor unless...

25 CFR 11.444 - Carrying concealed weapons.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 25 Indians 1 2012-04-01 2011-04-01 true Carrying concealed weapons. 11.444 Section 11.444 Indians... ORDER CODE Criminal Offenses § 11.444 Carrying concealed weapons. A person who goes about in public places armed with a dangerous weapon concealed upon his or her person is guilty of a misdemeanor unless...

Mental Layouts of Concealed Objects as a Function of Bizarre Imagery and Retention Interval.

ERIC Educational Resources Information Center

Iaccino, James; And Others

To determine whether concealed imagery was an effective mnemonic aid in the recall of paired objects, two studies were conducted with explicitly worded instructions to conceal targets and with variable image formation periods. In each study, 40 subjects were presented with counterbalanced verbal descriptions of Concealed, Pictorial, and Separate…

A generic minimization random allocation and blinding system on web.

PubMed

Cai, Hongwei; Xia, Jielai; Xu, Dezhong; Gao, Donghuai; Yan, Yongping

2006-12-01

Minimization is a dynamic randomization method for clinical trials. Although recommended by many researchers, the utilization of minimization has been seldom reported in randomized trials mainly because of the controversy surrounding the validity of conventional analyses and its complexity in implementation. However, both the statistical and clinical validity of minimization were demonstrated in recent studies. Minimization random allocation system integrated with blinding function that could facilitate the implementation of this method in general clinical trials has not been reported. SYSTEM OVERVIEW: The system is a web-based random allocation system using Pocock and Simon minimization method. It also supports multiple treatment arms within a trial, multiple simultaneous trials, and blinding without further programming. This system was constructed with generic database schema design method, Pocock and Simon minimization method and blinding method. It was coded with Microsoft Visual Basic and Active Server Pages (ASP) programming languages. And all dataset were managed with a Microsoft SQL Server database. Some critical programming codes were also provided. SIMULATIONS AND RESULTS: Two clinical trials were simulated simultaneously to test the system's applicability. Not only balanced groups but also blinded allocation results were achieved in both trials. Practical considerations for minimization method, the benefits, general applicability and drawbacks of the technique implemented in this system are discussed. Promising features of the proposed system are also summarized.

Mapping Fearscapes of a Mammalian Herbivore using Terrestrial LiDAR and UAV Imagery

NASA Astrophysics Data System (ADS)

Olsoy, P.; Nobler, J. D.; Forbey, J.; Rachlow, J. L.; Burgess, M. A.; Glenn, N. F.; Shipley, L. A.

2013-12-01

Concealment allows prey animals to remain hidden from a predator and can influence both real and perceived risks of predation. The heterogeneous nature of vegetative structure can create a variable landscape of concealment - a 'fearscape' - that may influence habitat quality and use by prey. Traditional measurements of concealment rely on a limited number of distances, heights, and vantage points, resulting in small snapshots of concealment available to a prey animal. Our objective was to demonstrate the benefits of emerging remote sensing techniques to map fearscapes for pygmy rabbits (Brachylagus idahoensis) in sagebrush steppe habitat across a continuous range of scales. Specifically, we used vegetation height rasters derived from terrestrial laser scanning (TLS) to create viewsheds from multiple vantage points, representing predator visibility. The sum of all the viewsheds modeled horizontal concealment of prey at both the shrub and patch scales. We also used a small, unmanned aerial vehicle (UAV) to determine vertical concealment at a habitat scale. Terrestrial laser scanning provided similar estimates of horizontal concealment at the shrub scale when compared to photographic methods (R2 = 0.85). Both TLS and UAV provide the potential to quantify concealment of prey from multiple distances, heights, or vantage points, allowing the creation of a manipulable fearscape map that can be correlated with habitat use by prey animals. The predictive power of such a map also could identify shrubs or patches for fine scale nutritional and concealment analysis for future investigation and conservation efforts. Fearscape map at the mound-scale. Viewsheds were calculated from 100 equally spaced observer points located 4 m from the closest on-mound sagebrush of interest. Red areas offer low concealment, while green areas provide high concealment.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

PubMed Central

2012-01-01

Background Small incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Methods/Design Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. Discussion This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Trial registration Clinicaltrials.gov NCT01216475. PMID:22647480

Statistical Power and Optimum Sample Allocation Ratio for Treatment and Control Having Unequal Costs Per Unit of Randomization

ERIC Educational Resources Information Center

Liu, Xiaofeng

2003-01-01

This article considers optimal sample allocation between the treatment and control condition in multilevel designs when the costs per sampling unit vary due to treatment assignment. Optimal unequal allocation may reduce the cost from that of a balanced design without sacrificing any power. The optimum sample allocation ratio depends only on the…

An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.

PubMed

Jepson, Marcus; Elliott, Daisy; Conefrey, Carmel; Wade, Julia; Rooshenas, Leila; Wilson, Caroline; Beard, David; Blazeby, Jane M; Birtle, Alison; Halliday, Alison; Stein, Rob; Donovan, Jenny L

2018-07-01

To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. Qualitative analysis of 73 audio recordings of recruitment consultations from five, multicenter, UK-based RCTs with identified or anticipated recruitment difficulties. One in 10 appointments did not include any mention of randomization. Most included a description of the method or process of allocation. Descriptions often made reference to gambling-related metaphors or similes, or referred to allocation by a computer. Where reference was made to a computer, some patients assumed that they would receive the treatment that was "best for them". Descriptions of the rationale for randomization were rarely present and often only came about as a consequence of patients questioning the reason for a random allocation. The methods and processes of randomization were usually described by recruiters, but often without clarity, which could lead to patient misunderstanding. The rationale for randomization was rarely mentioned. Recruiters should avoid problematic gambling metaphors and illusions of agency in their explanations and instead focus on clearer descriptions of the rationale and method of randomization to ensure patients are better informed about randomization and RCT participation. Copyright © 2018 University of Bristol. Published by Elsevier Inc. All rights reserved.

Modified constraint-induced therapy for children with hemiplegic cerebral palsy: a randomized trial.

PubMed

Wallen, Margaret; Ziviani, Jenny; Naylor, Olivia; Evans, Ruth; Novak, Iona; Herbert, Robert D

2011-12-01

Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study was to determine the effects of modified constraint-induced therapy compared with intensive occupational therapy on activities of daily living and upper limb outcomes in children with hemiplegic CP. In this assessor-blinded pragmatic randomized trial, 50 children (27 males, 23 females; age range 19 mo-7 y 10 mo) with hemiplegic CP were randomized using a concealed allocation procedure to one of two 8-week interventions: intensive occupational therapy (n = 25), or modified constraint-induced therapy (n = 25). Manual Ability Classification System (MACS) levels of the participants were, level I n = 2, II n = 37, III n = 8, and level IV n = 1; Gross Motor Function Classification System (GMFCS) levels were, level I n = 33, level II n = 15, and level III n = 1. Participants were recruited through three specialist CP centres in Australia and randomized between January 2008 and April 2010. Children randomized to modified constraint-induced therapy wore a mitt on the unaffected hand for 2 hours each day, during which time the children participated in targeted therapy. The primary outcome was the Canadian Occupational Performance Measure (COPM--measured on a 10-point scale) at completion of therapy. Other outcome measures were Goal Attainment Scaling, Assisting Hand Assessment, Pediatric Motor Activity Log, Modified Ashworth Scale, Modified Tardieu Scale, and a parent questionnaire. Assessments were carried out at 10 weeks and 6 months following randomization. All participants were included in the analysis. Between-group differences for all outcomes were neither clinically important nor statistically significant. The mean difference in COPM was 0.3 (95% confidence interval [CI] -0.8 to 1.4; p=0.61) and mean difference in COPM satisfaction was 0.1 (95% CI -1.1 to 1.2; p=0.90). Minor adverse events were reported by five of the 25 participants in the modified constraint-induced therapy group and by one of the 25 in the intensive occupational therapy group. All adverse events were related to participants' lack of acceptance of therapy. Modified constraint-induced therapy is no more effective than intensive occupational therapy for improving completion of activities of daily living or upper limb function in children with hemiplegic CP. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

PubMed

Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique Mj; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees Pj

2015-10-26

The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome. A randomized trial is needed to confirm these findings. We hypothesized that early AED withdrawal in children is not only safe, but also beneficial with respect to cognitive functioning. This is a multi-center pragmatic randomized clinical trial to investigate whether early AED withdrawal improves cognitive function, in terms of attention, executive function and intelligence, quality of life and behavior, and to confirm safety in terms of eventual seizure freedom, seizure recurrences and "seizure and AED freedom." Patients will be randomly allocated in parallel groups (1:1) to either early or late AED withdrawal. Randomization will be concealed and stratified for preoperative IQ and medical center. In the early withdrawal arm reduction of AEDs will start 4 months after surgery, while in the late withdrawal arm reduction starts 12 months after surgery, with intended complete cessation of drugs after 12 and 20 months respectively. Cognitive outcome measurements will be performed preoperatively, and at 1 and 2 years following surgery, and consist of assessment of attention and executive functioning using the EpiTrack Junior test and intelligence expressed as IQ (Wechsler Intelligence Scales). Seizure outcomes will be assessed at 24 months after surgery, and at 20 months following start of AED reduction. We aim to randomize 180 patients who underwent anticipated curative epilepsy surgery below 16 years of age, were able to perform the EpiTrack Junior test preoperatively, and have no predictors of poor postoperative seizure prognosis (multifocal magnetic resonance imaging (MRI) abnormalities, incomplete resection of the lesion, epileptic postoperative electroencephalogram (EEG) abnormalities, or more than three AEDs at the time of surgery). Growing experience with epilepsy surgery has changed the view towards postoperative medication policy. In a European collaboration, we designed a multi-center pragmatic randomized clinical trial comparing early with late AED withdrawal to investigate benefits and safety of early AED withdrawal. The TTS trial is supported by the Dutch Epilepsy Fund (NL 08-10) ISRCTN88423240/ 08/05/2013.

Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial.

PubMed

Meinich Petersen, Sandra; Zoffmann, Vibeke; Kjærgaard, Jesper; Graff Stensballe, Lone; Graff Steensballe, Lone; Greisen, Gorm

2014-04-15

When a child participates in a clinical trial, informed consent has to be given by the parents. Parental motives for participation are complex, but the hope of getting a new and better treatment for the child is important. We wondered how parents react when their child is allocated to the control group of a randomized controlled trial, and how it will affect their future engagement in the trial. We included parents of newborns randomized to the control arm in the Danish Calmette study at Rigshospitalet in Copenhagen. The Calmette study is a randomized clinical trial investigating the non-specific effects of early BCG-vaccine to healthy neonates. Randomization is performed immediately after birth and parents are not blinded to the allocation. We set up a semi-structured focus group with six parents from four families. Afterwards we telephone-interviewed another 19 mothers to achieve saturation. Thematic analysis was used to identify themes across the data sets. The parents reported good understanding of the randomization process. Their most common reaction to allocation was disappointment, though relief was also seen. A model of reactions to being allocated to the control group was developed based on the participants' different positions along two continuities from 'Our participation in trial is not important' to 'Our participation in trial is important', and 'Vaccine not important to us' to 'Vaccine important to us'. Four very disappointed families had thought of getting the vaccine elsewhere, and one had actually had their child vaccinated. All parents involved in the focus group and the telephone interviews wanted to participate in the follow-ups planned for the Calmette study. This study identified an almost universal experience of disappointment among parents of newborns who were randomized to the control group, but also a broad expression of understanding and accepting the idea of randomization. The trial staff might use the model of reactions in understanding the parents' disappointment and in this way support their motives for participation. A generalized version might be applicable across randomized controlled trials at large. The Calmette study is registered in EudraCT (https://eudract.ema.europa.eu/) with trial number 2010-021979-85.

Methological quality of systematic reviews and meta-analyses on acupuncture for stroke: A review of review.

PubMed

Chen, Xin-Lin; Mo, Chuan-Wei; Lu, Li-Ya; Gao, Ri-Yang; Xu, Qian; Wu, Min-Feng; Zhou, Qian-Yi; Hu, Yue; Zhou, Xuan; Li, Xian-Tao

2017-11-01

To assess the methodological quality of systematic reviews and meta-analyses regarding acupuncture intervention for stroke and the primary studies within them. Two researchers searched PubMed, Cumulative index to Nursing and Allied Health Literature, Embase, ISI Web of Knowledge, Cochrane, Allied and Complementary Medicine, Ovid Medline, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang and Traditional Chinese Medical Database to identify systematic reviews and meta-analyses about acupuncture for stroke published from the inception to December 2016. Review characteristics and the criteria for assessing the primary studies within reviews were extracted. The methodological quality of the reviews was assessed using adapted Oxman and Guyatt Scale. The methodological quality of primary studies was also assessed. Thirty-two eligible reviews were identified, 15 in English and 17 in Chinese. The English reviews were scored higher than the Chinese reviews (P=0.025), especially in criteria for avoiding bias and the scope of search. All reviews used the quality criteria to evaluate the methodological quality of primary studies, but some criteria were not comprehensive. The primary studies, in particular the Chinese reviews, had problems with randomization, allocation concealment, blinding, dropouts and withdrawals, intent-to-treat analysis and adverse events. Important methodological flaws were found in Chinese systematic reviews and primary studies. It was necessary to improve the methodological quality and reporting quality of both the systematic reviews published in China and primary studies on acupuncture for stroke.

A Systematic Review of the Effectiveness of Medical Cannabis for Psychiatric, Movement and Neurodegenerative Disorders.

PubMed

Lim, Keane; See, Yuen Mei; Lee, Jimmy

2017-11-30

The discovery of endocannabinoid's role within the central nervous system and its potential therapeutic benefits have brought forth rising interest in the use of cannabis for medical purposes. The present review aimed to synthesize and evaluate the available evidences on the efficacy of cannabis and its derivatives for psychiatric, neurodegenerative and movement disorders. A systematic search of randomized controlled trials of cannabis and its derivatives were conducted via databases (PubMed, Embase and the Cochrane Central Register of Controlled Trials). A total of 24 reports that evaluated the use of medical cannabis for Alzheimer's disease, anorexia nervosa, anxiety, dementia, dystonia, Huntington's disease, Parkinson's disease, post-traumatic stress disorder (PTSD), psychosis and Tourette syndrome were included in this review. Trial quality was assessed with the Cochrane risk of bias tool. There is a lack of evidence on the therapeutic effects of cannabinoids for amyotrophic lateral sclerosis and dystonia. Although trials with positive findings were identified for anorexia nervosa, anxiety, PTSD, psychotic symptoms, agitation in Alzheimer's disease and dementia, Huntington's disease, and Tourette syndrome, and dyskinesia in Parkinson's disease, definitive conclusion on its efficacy could not be drawn. Evaluation of these low-quality trials, as rated on the Cochrane risk of bias tools, was challenged by methodological issues such as inadequate description of allocation concealment, blinding and underpowered sample size. More adequately powered controlled trials that examine the long and short term efficacy, safety and tolerability of cannabis for medical use, and the mechanisms underpinning the therapeutic potential are warranted.

Campaign for Right to Carry Concealed Guns on Campuses Gains Traction

ERIC Educational Resources Information Center

Wiseman, Rachel

2012-01-01

Five years after the Virginia Tech massacre prompted a student in Texas to start a Facebook page in favor of the right to carry concealed weapons on college campuses, the resulting group, Students for Concealed Carry, has advanced its cause. In more than a dozen states, legislation has been introduced to allow the carrying of concealed firearms on…

Regulatory focus moderates the social performance of individuals who conceal a stigmatized identity.

PubMed

Newheiser, Anna-Kaisa; Barreto, Manuela; Ellemers, Naomi; Derks, Belle; Scheepers, Daan

2015-12-01

People often choose to hide a stigmatized identity to avoid bias. However, hiding stigma can disrupt social interactions. We considered whether regulatory focus qualifies the social effects of hiding stigma by examining interactions in which stigmatized participants concealed a devalued identity from non-stigmatized partners. In the Prevention Focus condition, stigmatized participants were instructed to prevent a negative impression by concealing the identity; in the Promotion Focus condition, they were instructed to promote a positive impression by concealing the identity; in the Control condition, they were simply asked to conceal the identity. Both non-stigmatized partners and independent raters rated the interactions more positively in the Promotion Focus condition. Thus, promotion focus is interpersonally beneficial for individuals who conceal a devalued identity. © 2015 The British Psychological Society.

Synaptic Tagging During Memory Allocation

PubMed Central

Rogerson, Thomas; Cai, Denise; Frank, Adam; Sano, Yoshitake; Shobe, Justin; Aranda, Manuel L.; Silva, Alcino J.

2014-01-01

There is now compelling evidence that the allocation of memory to specific neurons (neuronal allocation) and synapses (synaptic allocation) in a neurocircuit is not random and that instead specific mechanisms, such as increases in neuronal excitability and synaptic tagging and capture, determine the exact sites where memories are stored. We propose an integrated view of these processes, such that neuronal allocation, synaptic tagging and capture, spine clustering and metaplasticity reflect related aspects of memory allocation mechanisms. Importantly, the properties of these mechanisms suggest a set of rules that profoundly affect how memories are stored and recalled. PMID:24496410

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 1 2014-10-01 2014-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 1 2013-10-01 2013-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

47 CFR 1.1417 - Allocation of Unusable Space Costs.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 1 2012-10-01 2012-10-01 false Allocation of Unusable Space Costs. 1.1417... by Random Selection Pole Attachment Complaint Procedures § 1.1417 Allocation of Unusable Space Costs... providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing...

Attachment style, self-concealment, and interpersonal distance among Japanese undergraduates.

PubMed

Yukawa, Shintaro; Tokuda, Hideji; Sato, Jun

2007-06-01

The relationships among attachment style, self-concealment, and interpersonal distance were studied with 71 Japanese undergraduates (33 men and 38 women, ages 18 to 20 years, M = 18.7, SD= .6). Participants completed a questionnaire about Self-concealment and Attachment Styles (Secure, Anxious, and Avoidant). One week later, Interpersonal Distance, which individuals maintain between themselves and others, was measured by the stop-distance paradigm. Analysis showed that scores for more Anxious and Avoidant Attachment Styles were positively correlated with those for greater Self-concealment. Scores for greater Self-concealment and more Anxious Attachment Style were also correlated with longer Interpersonal Distance.

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

PubMed

Harrison, Eleanor F; Haines, Rachel H; Cowdell, Fiona; Sach, Tracey H; Dean, Taraneh; Pollock, Ian; Burrows, Nigel P; Buckley, Hannah; Batchelor, Jonathan; Williams, Hywel C; Lawton, Sandra; Brown, Sara J; Bradshaw, Lucy E; Ahmed, Amina; Montgomery, Alan A; Mitchell, Eleanor J; Thomas, Kim S

2015-09-02

Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete. Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series. Current Controlled Trials ISRCTN77261365 (registered 11 November 2013).

Comparison of pain perception during miniscrew placement in orthodontic patients with a visual analog scale survey between compound topical and needle-injected anesthetics: A crossover, prospective, randomized clinical trial.

PubMed

Lamberton, Jordan A; Oesterle, Larry J; Shellhart, W Craig; Newman, Sheldon M; Harrell, Ricky E; Tilliss, Terri; Singh, Neha; Carey, Clifton M

2016-01-01

The use of a compound topical anesthetic (CTA) instead of an injection of a local anesthetic for placing miniscrew implants offers advantages to both the clinician and the patient. The purpose of this crossover, prospective, randomized clinical trial was to compare the clinical effectiveness of a CTA with that of a needle injection of local anesthetic for miniscrew placement. Twenty-four orthodontic patients in a university clinic were recruited; they required bilateral buccal miniscrews for orthodontic anchorage. Eligibility criteria included healthy patients with no special needs; over 8 years of age and 25 pounds; not taking sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines; and not allergic to ester-type local anesthetics or any of the other materials used in the study. A computer generated a randomization list. The allocation was randomized by anesthetic protocol and side of the mouth, and was restricted to achieve balance by treatment and side of the mouth. No allocation concealment was applied. Associated with each randomized number was the subjects' assignment into 1 of 4 groups divided by the side of first miniscrew placement and the type of anesthetic. Blinding was done only for data analysis because of clinical limitations. Each patient received a CTA on one side and an injection of anesthetic on the other before miniscrew placement in a crossover study design. The outcome was assessed by measuring pain levels with a 100-mm visual analog scale at 5 time points. Anesthetic failures occurred when the miniscrew could not be fully comfortably placed with a given anesthetic. Data were organized by visual analog scale time points, and descriptive statistics were calculated. A factorial repeated-measures analysis of variance was used to determine any differences. Twenty-seven patients were assessed for eligibility, and 24 agreed to participate in the study. Patients did not distinguish any differences in pain between the application of the CTA and the injection before or during anesthetic placement, but they experienced more pain with the CTA during miniscrew placement. The mean difference for the entire procedure between the 2 anesthesia types was 24.6 units, and the 95% confidence interval was 18.8 to 30.4, a statistically significant finding (P = 0.0002). The CTA was still viewed as more painful 1 month after the procedures. Significantly more anesthetic failures occurred with the CTA (41.6%) than with the injection (0%). No serious harm was observed in any patient; when significant pain was observed with the CTA, a needle injection of local anesthetic was administered. CTAs provided less predictable, often inadequate, and less comfortable anesthesia than an injection of a local anesthetic for managing patient discomfort during miniscrew placement in buccal sites. This trial was not registered. The protocol was determined and approved by the research committee and institutional review board before the trial. No external funding was used other than the donation of the miniscrews from Rocky Mountain Orthodontics, and no conflict of interest was declared. Copyright © 2016. Published by Elsevier Inc.

Indirect vs direct bonding of mandibular fixed retainers in orthodontic patients: Comparison of retainer failures and posttreatment stability. A 2-year follow-up of a single-center randomized controlled trial.

PubMed

Egli, Fabienne; Bovali, Efstathia; Kiliaridis, Stavros; Cornelis, Marie A

2017-01-01

The objectives of this 2-arm parallel trial were to compare the numbers of failures of mandibular fixed retainers bonded with indirect and direct methods and to investigate the posttreatment changes 2 years after placement. Sixty-four consecutive patients from the postgraduate orthodontic clinic of the University of Geneva in Switzerland were randomly allocated to either an indirect or a traditional direct bonding procedure of a mandibular fixed retainer at the end of their orthodontic treatment (T0). Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4 (using an online randomization service) with allocation concealment secured by contacting the sequence generator for assignment. The patients were recalled 12 months and 24 months (T3) after retainer bonding. The main outcome was any first-time failure of retainers (ie, at least 1 composite pad debonded or fractured); unexpected posttreatment changes of the mandibular incisors and canines were a secondary outcome. Impressions and lateral cephalograms were taken at T0 and T3: changes in mandibular intercanine and interpremolar distances and mandibular incisor inclination were assessed. Blinding was applicable for outcome assessment only. The chi-square test and Cox regression were used to compare the survival rates of the retainers bonded with direct and indirect methods. Paired t tests were used to assess differences in intercanine and interpremolar distances and mandibular incisor inclination at T0 and T3. Significance was set at P <0.05. Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline, and 3 patients did not reach the T3 recall. In 24 of 60 (40%) patients, the fixed retainer failed within 2 years: 13 of 30 (43%) in the indirect bonding group and 11 of 30 (37%) in the direct bonding group (log-rank test, P = 0.64). The hazard ratio was 1.26 (95% confidence interval, 0.56-2.81; P = 0.58). Bond failures occurred mainly during the first year. There were no clinically significant changes in mandibular intercanine distance, interpremolar distance, and incisor inclination between T0 and T3, or between groups. In 5 patients (17%), all in the direct bonding group, unexpected posttreatment changes, systematically consisting in a lingual inclination of the mandibular left canine, were observed. In 1 patient (3%), the change was considered clinically severe. No other serious harm was observed. There was no difference in the risks of failure between mandibular retainers bonded with direct and indirect methods. Bonded retainers are effective in maintaining intercanine and interpremolar distances. There seem to be fewer unexpected posttreatment changes with retainers bonded with the indirect compared with the direct method. The trial was not registered. The protocol was not published before trial commencement. No funding or conflict of interest to be declared. Copyright © 2017 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

The Effect of Trimethoprim on Serum Folate Levels in Humans: A Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Meidahl Petersen, Kasper; Eplov, Kasper; Kjær Nielsen, Torben; Jimenez-Solem, Espen; Petersen, Morten; Broedbaek, Kasper; Daugaard Popik, Sara; Kallehave Hansen, Lina; Enghusen Poulsen, Henrik; Trærup Andersen, Jon

2016-01-01

Trimethoprim antagonize the actions of folate by inhibition of dihydrofolate reductase. This could diminish serum folate levels in humans and causes folate deficiency in some patients. We conducted a randomized, double-blind, placebo-controlled trial, to investigate the effect of trimethoprim on serum folate levels in healthy participants after a 7-day trial period. Thirty young, healthy males were randomly allocated to receive trimethoprim, 200 mg twice daily, and 30 were randomly allocated to placebo. Before trial initiation, participant numbers were given randomly generated treatment allocations within sealed opaque envelopes. Participants and all staff were kept blinded to treatment allocations during the trial. Serum folate was measured at baseline and at end of trial. In the 58 participants analyzed (30 in the trimethoprim group and 28 in the placebo group), 8 had folate deficiency at baseline. Within the trimethoprim group, serum folate was significantly decreased (P = 0.018) after the trial. We found a mean decrease in serum folate among trimethoprim exposed of 1.95 nmol/L, compared with a 0.21 nmol/L mean increase in the placebo group (P = 0.040). The proportion of folate-deficient participants increased significantly within the trimethoprim group (P = 0.034). No serious adverse events were observed. In conclusion, we found that a daily dose of 400 mg trimethoprim for 7 days significantly lowered serum folate levels in healthy study participants.

Concealing Emotions at Work Is Associated with Allergic Rhinitis in Korea.

PubMed

Seok, Hongdeok; Yoon, Jin-Ha; Won, Jong-Uk; Lee, Wanhyung; Lee, June-Hee; Jung, Pil Kyun; Roh, Jaehoon

2016-01-01

Concealing emotions at work can cause considerable psychological stress. While there is extensive research on the adverse health effects of concealing emotions and the association between allergic diseases and stress, research has not yet investigated whether concealing emotions at work is associated with allergic rhinitis. Allergic rhinitis is a common disease in many industrialized countries, and its prevalence is increasing. Thus, our aim was to determine the strength of this association using data from three years (2007-2009) of the 4th Korean National Health and Nutrition Examination Survey. Participants (aged 20-64) were 8,345 individuals who were economically active and who had completed the questionnaire items on concealing emotions at work. Odds ratio (OR) and 95% confidence intervals (95% CIs) were calculated for allergic rhinitis using logistic regression models. Among all participants, 3,140 subjects (37.6%) reported concealing their emotions at work: 1,661 men and 1,479 women. The OR (95% CIs) for allergic rhinitis among those who concealed emotions at work versus those who did not was 1.318 (1.148-1.512). Stratified by sex, the OR (95% CIs) was 1.307 (1.078-1.585) among men and 1.346 (1.105-1.639) among women. Thus, individuals who concealed their emotions at work were significantly more likely to have a diagnosis of AR in comparison to those who did not. Because concealing emotions at work has adverse health effects, labor policies that aim to reduce this practice are needed.

RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

PubMed

Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

2015-08-01

Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

Method for imaging a concealed object

DOEpatents

Davidson, James R [Idaho Falls, ID; Partin, Judy K [Idaho Falls, ID; Sawyers, Robert J [Idaho Falls, ID

2007-07-03

A method for imaging a concealed object is described and which includes a step of providing a heat radiating body, and wherein an object to be detected is concealed on the heat radiating body; imaging the heat radiating body to provide a visibly discernible infrared image of the heat radiating body; and determining if the visibly discernible infrared image of the heat radiating body is masked by the presence of the concealed object.

Impact of frequency and polarization diversity on a terahertz radar's imaging performance

NASA Astrophysics Data System (ADS)

Cooper, Ken B.; Dengler, Robert J.; Llombart, Nuria

2011-05-01

The Jet Propulsion Laboratory's 675 GHz, 25 m standoff imaging radar can achieve >1 Hz real time frame rates over 40x40 cm fields of view for rapid detection of person-borne concealed weapons. In its normal mode of operation, the radar generates imagery based solely on the time-of-flight, or range, between the radar and target. With good clothing penetration at 675 GHz, a hidden object will be detectable as an anomaly in the range-to-surface profile of a subject. Here we report on results of two modifications in the radar system that were made to asses its performance using somewhat different detection approaches. First, the radar's operating frequency and bandwidth were cut in half, to 340 GHz and 13 GHz, where there potential system advantages include superior transmit power and clothing penetration, as well as a lower cost of components. In this case, we found that the twofold reduction in range and cross-range resolution sharply limited the quality of through-clothes imagery, although some improvement is observed for detection of large targets concealed by very thick clothing. The second radar modification tested involved operation in a fully polarimetric mode, where enhanced image contrast might occur between surfaces with different material or geometric characteristics. Results from these tests indicated that random speckle dominates polarimetric power imagery, making it an unattractive approach for contrast improvement. Taken together, the experiments described here underscore the primary importance of high resolution imaging in THz radar applications for concealed weapons detection.

Video error concealment using block matching and frequency selective extrapolation algorithms

NASA Astrophysics Data System (ADS)

P. K., Rajani; Khaparde, Arti

2017-06-01

Error Concealment (EC) is a technique at the decoder side to hide the transmission errors. It is done by analyzing the spatial or temporal information from available video frames. It is very important to recover distorted video because they are used for various applications such as video-telephone, video-conference, TV, DVD, internet video streaming, video games etc .Retransmission-based and resilient-based methods, are also used for error removal. But these methods add delay and redundant data. So error concealment is the best option for error hiding. In this paper, the error concealment methods such as Block Matching error concealment algorithm is compared with Frequency Selective Extrapolation algorithm. Both the works are based on concealment of manually error video frames as input. The parameter used for objective quality measurement was PSNR (Peak Signal to Noise Ratio) and SSIM(Structural Similarity Index). The original video frames along with error video frames are compared with both the Error concealment algorithms. According to simulation results, Frequency Selective Extrapolation is showing better quality measures such as 48% improved PSNR and 94% increased SSIM than Block Matching Algorithm.

Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis.

PubMed

Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

2017-03-01

We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Studies evaluating CHM often fail to meet expected methodological criteria, and high-quality evidence is lacking. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Comparative assessment of fluoride varnish and fluoride film for remineralization of postorthodontic white spot lesions in adolescents and adults over a 6-month period: A single-center, randomized controlled clinical trial.

PubMed

He, Tao; Li, Xue; Dong, Ying; Zhang, Na; Zhong, Yisi; Yin, Wei; Hu, Deyu

2016-06-01

The objective of this 3-arm parallel randomized trial was to evaluate the effects of a fluoride varnish and a fluoride film on the remineralization of white spot lesions around orthodontic brackets after orthodontic treatment. Patients who had recently completed orthodontic treatment were randomly assigned to the varnish, film, and control groups. Eligibility criteria included age of 12 to 25 years, good general health, and at least 1 maxillary anterior tooth with a white spot lesion. The primary outcome was the decrease in the lesion volume of each patient after 6 months of treatment; fluorescence loss and area were the secondary outcome measures. Randomization was accomplished according to a computer-generated randomization schedule, and allocation concealment was achieved with nontransparent concealed envelopes. Blinding was applicable for the treatments only. The test groups received fluoride varnish or film treatment once a month for 6 months, and the control group received a placebo treatment. All patients received oral hygiene education and were required to use fluoride toothpaste daily. Quantitative light-induced fluorescence images were taken at baseline and at the 3-month and 6-month follow-ups. A mixed-effects linear model was used to analyze quantitative light-induced fluorescence parameters with confounders integrated into the model. Two hundred forty patients (mean age, 16.9 years; range, 12-25 years) with 597 teeth with a white spot lesion were randomized 1:1:1 to the varnish, film, and control groups. Baseline demographics were similar between groups, and 29 patients were lost to follow-up. The primary analysis was carried out on a per-protocol basis involving 72 patients in the control group, 69 patients in the varnish group, and 70 patients in the film group who completed the study. The product of fluorescence loss and lesion area values were statistically associated with time (estimate, -4.58; 95% confidence interval [CI], -5.84 to -3.31; P <0.0001), and a significant decrease in the product of fluorescence loss and lesion area was observed in all groups after 6 months with each treatment. The interaction between group and time in the statistical analysis indicated that the product of fluorescence loss and lesion area values of the 3 groups followed different trends over time. Further pair-wise comparisons showed that the decreases in the 2 test groups were significantly greater than those in the control group (varnish vs control: estimate, -11.83; 95% CI, -15.39 to -8.26; P <0.0001; film vs control, estimate: -7.72; 95% CI, -11.34 to 4.10; P <0.0001) in the analysis for 6 months. In addition, the decrease in the varnish group was significantly greater than that in the film group (estimate, 4.11; 95% CI, 0.48 to 7.73; P = 0.0266) in the analysis for 6 months. No serious adverse effects associated with the use of the tested varnish, film, or placebo occurred. After removal of the orthodontic brackets, some natural remineralization of white spot lesions occurred, and daily use of fluoride toothpaste may be helpful for this process. However, not all patients experienced this remineralization, and treatment with fluoride varnish or fluoride film induced greater remineralization of white spot lesions. In addition, our results suggest that fluoride varnish may be slightly more effective than fluoride film. However, further similar clinical trials with more patients are needed to definitively determine which fluoride treatment is most effective. This trial was registered on the Chinese Clinical Trial Register, number ChiCTR-TRC-13003764. The details of the trial protocol are posted online at: http://apps.who.int/trialsearch/Trial.aspx?TrialID=ChiCTR-TRC-13003764. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Effect of maxillary protraction with alternating rapid palatal expansion and constriction vs expansion alone in maxillary retrusive patients: a single-center, randomized controlled trial.

PubMed

Liu, Weitao; Zhou, Yanheng; Wang, Xuedong; Liu, Dawei; Zhou, Shaonan

2015-10-01

The objective of this randomized controlled trial was to investigate the effects of facemask protraction combined with alternating rapid palatal expansion and constriction (RPE/C) vs rapid palatal expansion (RPE) alone in the early treatment of maxillary retrusive patients. Patients with a midface deficiency were recruited and randomly allocated into either the control group (RPE) or the intervention group (RPE/C). Eligibility criteria included the following: age 7 to 13 years old, Class III malocclusion, anterior crossbite, ANB less than 0°, Wits appraisal less than -2 mm, A-Np less than 0 mm, and no cleft of lip or palate. The primary outcome was the degree of maxillary forward movement after treatment. The secondary outcomes were the changes of the other cephalometric variables after treatment and the treatment time. Simple randomization was carried out using a random number table at the beginning of the study. Envelopes containing the grouping information were used to ensure allocation concealment from the researchers. Blinding was applicable for cephalometric analysis only. Hyrax palatal expanders and facemask maxillary protraction were used in all patients. Patients in the RPE group were treated with rapid palatal expansion for 1 week. Patients in the RPE/C group were treated with RPE/C for 7 weeks. The expansion or constriction rate was 1 mm per day. Cephalometric analysis with traditional cephalometric measurements and an x-y coordinate system were used to compare the pretreatment and posttreatment cephalometric radiographs. Independent t tests were used to compare the data between the 2 groups. A total of 44 patients were randomized to either the RPE group or the RPE/C group in a 1:1 ratio. One subject in the RPE group was lost to follow-up during the treatment. Per-protocol analysis was used. All the other 43 patients reached the treatment completion criteria and were analyzed (RPE group: n = 21; RPE/C group: n = 22). The average protraction time was 10.84 months in the RPE group, which was significantly longer than that in the RPE/C group (9.06 months) (effect size [ES], 1.78 [95% CI, 0.15, 3.42; P = 0.033]). Maxillary forward movement increased by 3.04 mm in the RPE/C group, which was significantly greater than that in the RPE group (2.11 mm) (ES, -0.93 [95% CI, -1.65, -0.20; P = 0.013]). The counterclockwise rotation of the palatal plane was 1.73° in the RPE/C group, which was significantly greater than that in the RPE group (0.83°) (ES, 0.90 [95% CI, 0.08, 1.73; P = 0.033]). The degree of mandibular downward and backward rotation was significantly smaller in the RPE/C group (P <0.05). No serious harm was observed during treatment and research. Facemask maxillary protraction with RPE/C might positively affect the forward movement of the maxilla compared with facemask protraction with RPE alone in the early treatment of maxillary retrusive patients. Although the differences between the groups were statistically significant for forward movement of the maxilla and rotation of the palatal and mandibular planes, these may not be clinically relevant, since the differences were less than 1 mm and 1°, respectively. This trial was not registered. The protocol was not published before trial commencement. This research was supported by Peking University Research Fund. No conflict of interest is declared. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Effects of massage therapy and occlusal splint therapy on electromyographic activity and the intensity of signs and symptoms in individuals with temporomandibular disorder and sleep bruxism: a randomized clinical trial.

PubMed

Gomes, Cid André Fidelis de Paula; El Hage, Yasmin; Amaral, Ana Paula; Politti, Fabiano; Biasotto-Gonzalez, Daniela Aparecida

2014-01-01

Temporomandibular disorder (TDM) is the most common source of orofacial pain of a non-dental origin. Sleep bruxism is characterized by clenching and/or grinding the teeth during sleep and is involved in the perpetuation of TMD. The aim of the present study was to investigate the effects of massage therapy, conventional occlusal splint therapy and silicone occlusal splint therapy on electromyographic activity in the masseter and anterior temporal muscles and the intensity of signs and symptoms in individuals with severe TMD and sleep bruxism. Sixty individuals with severe TMD and sleep bruxism were randomly distributed into four treatment groups: 1) massage group, 2) conventional occlusal splint group, 3) massage + conventional occlusal splint group and 4) silicone occlusal splint group. Block randomization was employed and sealed opaque envelopes were used to conceal the allocation. Groups 2, 3 and 4 wore an occlusal splint for four weeks. Groups 1 and 3 received three weekly massage sessions for four weeks. All groups were evaluated before and after treatment through electromyographic analysis of the masseter and anterior temporal muscles and the Fonseca Patient History Index. The Wilcoxon test was used to compare the effects of the different treatments and repeated-measures ANOVA was used to determine the intensity of TMD. The inter-group analysis of variance revealed no statistically significant differences in median frequency among the groups prior to treatment. In the intra-group analysis, no statistically significant differences were found between pre-treatment and post-treatment evaluations in any of the groups. Group 3 demonstrated a greater improvement in the intensity of TMD in comparison to the other groups. Massage therapy and the use of an occlusal splint had no significant influence on electromyographic activity of the masseter or anterior temporal muscles. However, the combination of therapies led to a reduction in the intensity of signs and symptoms among individuals with severe TMD and sleep bruxism. This study is registered in August, 2014 in the ClinicalTrials.gov (NCT01874041).

Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa.

PubMed

Ndounga Diakou, Lee Aymar; Ntoumi, Francine; Ravaud, Philippe; Boutron, Isabelle

2017-07-05

Randomized controlled trials (RCTs) are needed to improve health care in Sub-Saharan Africa (SSA). However, inadequate methods and incomplete reporting of interventions can prevent the transposition of research in practice which leads waste of research. The aim of this systematic review was to assess the avoidable waste in research related to inadequate methods and incomplete reporting of interventions in RCTs performed in SSA. We performed a methodological systematic review of RCTs performed in SSA and published between 1 January 2014 and 31 March 2015. We searched PubMed, the Cochrane library and the African Index Medicus to identify reports. We assessed the risk of bias using the Cochrane Risk of Bias tool, and for each risk of bias item, determined whether easy adjustments with no or minor cost could change the domain to low risk of bias. The reporting of interventions was assessed by using standardized checklists based on the Consolidated Standards for Reporting Trials, and core items of the Template for Intervention Description and Replication. Corresponding authors of reports with incomplete reporting of interventions were contacted to obtain additional information. Data were descriptively analyzed. Among 121 RCTs selected, 74 (61%) evaluated pharmacological treatments (PTs), including drugs and nutritional supplements; and 47 (39%) nonpharmacological treatments (NPTs) (40 participative interventions, 1 surgical procedure, 3 medical devices and 3 therapeutic strategies). Overall, the randomization sequence was adequately generated in 76 reports (62%) and the intervention allocation concealed in 48 (39%). The primary outcome was described as blinded in 46 reports (38%), and incomplete outcome data were adequately addressed in 78 (64%). Applying easy methodological adjustments with no or minor additional cost to trials with at least one domain at high risk of bias could have reduced the number of domains at high risk for 24 RCTs (19%). Interventions were completely reported for 73/121 (60%) RCTs: 51/74 (68%) of PTs and 22/47 (46%) of NPTs. Additional information was obtained from corresponding authors for 11/48 reports (22%). Inadequate methods and incomplete reporting of published SSA RCTs could be improved by easy and inexpensive methodological adjustments and adherence to reporting guidelines.

Acupuncture for ankle sprain: systematic review and meta-analysis

PubMed Central

2013-01-01

Background Ankle sprain is one of the most frequently encountered musculoskeletal injuries; however, the efficacy of acupuncture in treating ankle sprains remains uncertain. We therefore performed a systematic review to evaluate the evidence regarding acupuncture for ankle sprains. Methods We searched 15 data sources and two trial registries up to February 2012. Randomized controlled trials of acupuncture were included if they involved patients with ankle sprains and reported outcomes of symptom improvement, including pain. A Cochrane risk of bias assessment tool was used. Risk ratio (RR) or mean difference (MD) was calculated with 95% confidence intervals (CIs) in a random effects model. Subgroup analyses were performed based on acupuncture type, grade of sprain, and control type. Sensitivity analyses were also performed with respect to risk of bias, sample size, and outcomes reported. Results Seventeen trials involving 1820 participants were included. Trial quality was generally poor, with just three reporting adequate methods of randomization and only one a method of allocation concealment. Significantly more participants in acupuncture groups reported global symptom improvement compared with no acupuncture groups (RR of symptoms persisting with acupuncture = 0.56, 95% CI 0.42–0.77). However, this is probably an overestimate due to the heterogeneity (I2 = 51%) and high risk of bias of the included studies. Acupuncture as an add-on treatment also improved global symptoms compared with other treatments only, without significant variability (RR 0.61, 95% CI 0.51–0.73, I2 = 1%). The benefit of acupuncture remained significant when the analysis was limited to two studies with a low risk of bias. Acupuncture was more effective than various controls in relieving pain, facilitating return to normal activity, and promoting quality of life, but these analyses were based on only a small number of studies. Acupuncture did not appear to be associated with adverse events. Conclusions Given methodological shortcomings and the small number of high-quality primary studies, the available evidence is insufficient to recommend acupuncture as an evidence-based treatment option. This calls for further rigorous investigations. PMID:23496981

Complementary and Alternative Medicine for Management of Premature Ejaculation: A Systematic Review.

PubMed

Cooper, Katy; Martyn-St James, Marrissa; Kaltenthaler, Eva; Dickinson, Kath; Cantrell, Anna; Ren, Shijie; Wylie, Kevan; Frodsham, Leila; Hood, Catherine

2017-03-01

Premature ejaculation (PE) is defined as ejaculation within 1 minute (lifelong PE) or 3 minutes (acquired PE), inability to delay ejaculation, and negative personal consequences. Management includes behavioral and pharmacologic approaches. To systematically review effectiveness, safety, and robustness of evidence for complementary and alternative medicine in managing PE. Nine databases including Medline were searched through September 2015. Randomized controlled trials evaluating complementary and alternative medicine for PE were included. Studies were included if they reported on intravaginal ejaculatory latency time (IELT) and/or another validated PE measurement. Adverse effects were summarized. Ten randomized controlled trials were included. Two assessed acupuncture, five assessed Chinese herbal medicine, one assessed Ayurvedic herbal medicine, and two assessed topical "severance secret" cream. Risk of bias was unclear in all studies because of unclear allocation concealment or blinding, and only five studies reported stopwatch-measured IELT. Acupuncture slightly increased IELT over placebo in one study (mean difference [MD] = 0.55 minute, P = .001). In another study, Ayurvedic herbal medicine slightly increased IELT over placebo (MD = 0.80 minute, P = .001). Topical severance secret cream increased IELT over placebo in two studies (MD = 8.60 minutes, P < .001), although inclusion criteria were broad (IELT < 3 minutes). Three studies comparing Chinese herbal medicine with selective serotonin reuptake inhibitors (SSRIs) favored SSRIs (MD = 1.01 minutes, P = .02). However, combination treatment with Chinese medicine plus SSRIs improved IELT over SSRIs alone (two studies; MD = 1.92 minutes, P < .00001) and over Chinese medicine alone (two studies; MD = 2.52 minutes, P < .00001). Adverse effects were not consistently assessed but where reported were generally mild. There is preliminary evidence for the effectiveness of acupuncture, Chinese herbal medicine, Ayurvedic herbal medicine, and topical severance secret cream in improving IELT and other outcomes. However, results are based on clinically heterogeneous studies of unclear quality. There are sparse data on adverse effects or potential for drug interactions. Further well-conducted randomized controlled trials would be valuable. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Efficacy of Nasal Mometasone for the Treatment of Chronic Sinonasal Disease in Inadequately Controlled Asthma

PubMed Central

Dixon, Anne E.; Castro, Mario; Cohen, Rubin I.; Gerald, Lynn B.; Holbrook, Janet T.; Irvin, Charles G.; Mohapatra, Shyam; Peters, Stephen P.; Rayapudi, Sobharani; Sugar, Elizabeth A.; Wise, Robert A.

2014-01-01

Background Chronic sinonasal disease is common in asthma and associated with poor asthma control; however there are no long term trials addressing whether chronic treatment of sinonasal disease improves asthma control. Objective To determine if treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control as measured by the Childhood Asthma Control Test (cACT) and Asthma Control Test (ACT) in children and adults respectively. Methods A 24 week multi-center randomized placebo controlled double-blinded trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma. Treatments were randomly assigned with concealment of allocation. Results 237 adults and 151 children were randomized to nasal mometasone versus placebo, 319 participants completed the study. There was no difference in the cACT (difference in change with mometasone – change with placebo [ΔM - ΔP]: -0.38, CI: -2.19 to 1.44, p = 0.68 ages 6 to 11) or the ACT (ΔM - ΔP: 0.51, CI: -0.46 to 1.48, p = 0.30, ages 12 and older) in those assigned to mometasone versus placebo. In children and adolescents, ages 6 to 17, there was no difference in asthma or sinus symptoms, but a decrease in episodes of poorly controlled asthma defined by a drop in peak flow. In adults there was a small difference in asthma symptoms measured by the Asthma Symptom Utility Index (ΔM - ΔP: 0.06, CI: 0.01 to 0.11, p <0.01) and in nasal symptoms (sinus symptom score ΔM - ΔP: -3.82, CI: -7.19 to- 0.45, p =0.03), but no difference in asthma quality of life, lung function or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo. Conclusions Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthma should be determined by the need to treat sinonasal disease rather than to improve asthma control. PMID:25174863

Effects of chocolate, cocoa, and flavan-3-ols on cardiovascular health: a systematic review and meta-analysis of randomized trials.

PubMed

Hooper, Lee; Kay, Colin; Abdelhamid, Asmaa; Kroon, Paul A; Cohn, Jeffrey S; Rimm, Eric B; Cassidy, Aedín

2012-03-01

There is substantial interest in chocolate and flavan-3-ols for the prevention of cardiovascular disease (CVD). The objective was to systematically review the effects of chocolate, cocoa, and flavan-3-ols on major CVD risk factors. We searched Medline, EMBASE, and Cochrane databases for randomized controlled trials (RCTs) of chocolate, cocoa, or flavan-3-ols. We contacted authors for additional data and conducted duplicate assessment of study inclusion, data extraction, validity, and random-effects meta-analyses. We included 42 acute or short-term chronic (≤18 wk) RCTs that comprised 1297 participants. Insulin resistance (HOMA-IR: -0.67; 95% CI: -0.98, -0.36) was improved by chocolate or cocoa due to significant reductions in serum insulin. Flow-mediated dilatation (FMD) improved after chronic (1.34%; 95% CI: 1.00%, 1.68%) and acute (3.19%; 95% CI: 2.04%, 4.33%) intakes. Effects on HOMA-IR and FMD remained stable to sensitivity analyses. We observed reductions in diastolic blood pressure (BP; -1.60 mm Hg; 95% CI: -2.77, -0.43 mm Hg) and mean arterial pressure (-1.64 mm Hg; 95% CI: -3.27, -0.01 mm Hg) and marginally significant effects on LDL (-0.07 mmol/L; 95% CI: -0.13, 0.00 mmol/L) and HDL (0.03 mmol/L; 95% CI: 0.00, 0.06 mmol/L) cholesterol. Chocolate or cocoa improved FMD regardless of the dose consumed, whereas doses >50 mg epicatechin/d resulted in greater effects on systolic and diastolic BP. GRADE (Grading of Recommendations, Assessment, Development and Evaluation, a tool to assess quality of evidence and strength of recommendations) suggested low- to moderate-quality evidence of beneficial effects, with no suggestion of negative effects. The strength of evidence was lowered due to unclear reporting for allocation concealment, dropouts, missing data on outcomes, and heterogeneity in biomarker results in some studies. We found consistent acute and chronic benefits of chocolate or cocoa on FMD and previously unreported promising effects on insulin and HOMA-IR. Larger, longer-duration, and independently funded trials are required to confirm the potential cardiovascular benefits of cocoa flavan-3-ols.

Meta-analysis of organizational skills interventions for children and adolescents with Attention-Deficit/Hyperactivity Disorder.

PubMed

Bikic, Aida; Reichow, Brian; McCauley, Spencer A; Ibrahim, Karim; Sukhodolsky, Denis G

2017-03-01

In addition to problems with attention and hyperactivity, children with ADHD present with poor organizational skills required for managing time and materials in academic projects. Organizational skills training (OST) has been increasingly used to address these deficits. We conducted a systematic review and meta-analysis of OST in children with ADHD. The objective of this study was to systematically review the evidence of the effects of OST for children with ADHD for organizational skills, attention, and academic performance. We searched 3 electronic databases to locate randomized controlled trials published in English in peer-reviewed journals comparing OST with parent education, treatment-as-usual, or waitlist control conditions. Standardized mean difference effect sizes from the studies were statistically combined using a random-effects meta-analyses across six outcomes: teacher- and parent-rated organizational skills, teacher- and parent-rated inattention, teacher-rated academic performance, and Grade Point Average (GPA). Risk of bias was assessed for randomization, allocation concealment, blinding of participants and treatment personnel, blinding of outcome assessors, incomplete outcome data, and selective outcome reporting. Twelve studies involving 1054 children (576 treatment, 478 control) were included in the meta-analyses. Weighted mean effect sizes for teacher- and parent-rated outcome measures of organizational skills were g=0.54 (95% CI 0.17 to 0.91) and g=0.83 (95% CI 0.32 to 1.34), respectively. Weighted mean effect sizes of teacher- and parent-rated symptoms of inattention were g=0.26 (95% CI 0.01 to 0.52) and g=0.56 (95% CI 0.38 to 0.74), respectively. Weighted standardized mean effect size for teacher-rated academic performance and GPA were g=0.33 (95% CI 0.14 to 0.51) and g=0.29 (95% CI 0.07 to 0.51), respectively. OST leads to moderate improvements in organizational skills of children with ADHD as rated by teachers and large improvements as rated by parents. More modest improvements were observed on the ratings of symptoms of inattention and academic performance. PROSPERO (CRD42015019261). Copyright © 2016 Elsevier Ltd. All rights reserved.

Daily oral tenofovir and emtricitabine-tenofovir preexposure prophylaxis reduces herpes simplex virus type 2 acquisition among heterosexual HIV-1-uninfected men and women: a subgroup analysis of a randomized trial.

PubMed

Celum, Connie; Morrow, Rhoda A; Donnell, Deborah; Hong, Ting; Hendrix, Craig W; Thomas, Katherine K; Fife, Kenneth H; Nakku-Joloba, Edith; Mujugira, Andrew; Baeten, Jared M

2014-07-01

Daily oral preexposure prophylaxis (PrEP) using the antiretroviral tenofovir disoproxil fumarate (TDF) alone or in combination with emtricitabine (FTC-TDF) reduces the risk for HIV-1 acquisition. Tenofovir has in vitro activity against herpes simplex virus type 2 (HSV-2). To assess the efficacy of daily oral PrEP with tenofovir and FTC-TDF in the prevention of HSV-2 acquisition. Subgroup analysis of data from a randomized, placebo-controlled trial with concealed allocation. (ClinicalTrials.gov: NCT00557245). Multiple sites in Kenya and Uganda. Heterosexual men and women who were seronegative for HIV-1 and HSV-2 and at high risk for HIV-1 acquisition due to having an HIV-1-infected partner. Once-daily oral tenofovir disoproxil fumarate (TDF), alone or combined with emtricitabine (FTC-TDF), compared with placebo. HSV-2 seroconversion. A total of 131 participants seroconverted to HSV-2 (79 of 1041 assigned to tenofovir or FTC-TDF PrEP [HSV-2 incidence, 5.6 per 100 person-years] and 52 of 481 assigned to placebo [HSV-2 incidence, 7.7 per 100 person-years]). The hazard ratio (HR) for HSV-2 acquisition with daily oral PrEP was 0.70 (95% CI, 0.49 to 0.99; P = 0.047) compared with placebo, and the absolute risk reduction was 2.1 per 100 person-years. Among the 1044 participants with HSV-2-infected partners, the HR for PrEP was 0.67 (CI, 0.46 to 0.98; P = 0.038) compared with placebo, and the absolute risk reduction was 3.1 per 100 person-years. Randomization was not stratified by HSV-2 status, and diagnostic tests to exclude participants with acute HSV-2 at baseline are not available. Daily oral tenofovir-based PrEP significantly reduced the risk for HSV-2 acquisition among heterosexual men and women. Modest protection against HSV-2 is an added benefit of HIV-1 prevention with oral tenofovir-based PrEP. Bill & Melinda Gates Foundation.

Acupuncture for ankle sprain: systematic review and meta-analysis.

PubMed

Park, Jimin; Hahn, Seokyung; Park, Ji-Yeun; Park, Hi-Joon; Lee, Hyangsook

2013-03-04

Ankle sprain is one of the most frequently encountered musculoskeletal injuries; however, the efficacy of acupuncture in treating ankle sprains remains uncertain. We therefore performed a systematic review to evaluate the evidence regarding acupuncture for ankle sprains. We searched 15 data sources and two trial registries up to February 2012. Randomized controlled trials of acupuncture were included if they involved patients with ankle sprains and reported outcomes of symptom improvement, including pain. A Cochrane risk of bias assessment tool was used. Risk ratio (RR) or mean difference (MD) was calculated with 95% confidence intervals (CIs) in a random effects model. Subgroup analyses were performed based on acupuncture type, grade of sprain, and control type. Sensitivity analyses were also performed with respect to risk of bias, sample size, and outcomes reported. Seventeen trials involving 1820 participants were included. Trial quality was generally poor, with just three reporting adequate methods of randomization and only one a method of allocation concealment. Significantly more participants in acupuncture groups reported global symptom improvement compared with no acupuncture groups (RR of symptoms persisting with acupuncture = 0.56, 95% CI 0.42-0.77). However, this is probably an overestimate due to the heterogeneity (I2 = 51%) and high risk of bias of the included studies. Acupuncture as an add-on treatment also improved global symptoms compared with other treatments only, without significant variability (RR 0.61, 95% CI 0.51-0.73, I2 = 1%). The benefit of acupuncture remained significant when the analysis was limited to two studies with a low risk of bias. Acupuncture was more effective than various controls in relieving pain, facilitating return to normal activity, and promoting quality of life, but these analyses were based on only a small number of studies. Acupuncture did not appear to be associated with adverse events. Given methodological shortcomings and the small number of high-quality primary studies, the available evidence is insufficient to recommend acupuncture as an evidence-based treatment option. This calls for further rigorous investigations.

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

PubMed

Bilger, Marcel; Wong, Tina T; Howard, Kaye L; Lee, Jia Yi; Toh, Ai Nee; John, Geraldine; Lamoureux, Ecosse L; Finkelstein, Eric A

2016-07-15

Many glaucoma patients do not adhere to their medication regimens because they fail to internalize the (health) costs of non-adherence, which may not occur until years or decades later. Behavioural economic theory suggests that adherence rates can be improved by offering patients a near-term benefit. Our proposed strategy is to offer adherence-contingent rebates on medication and check-up costs. This form of value pricing (VP) ensures that rebates are granted only to those most likely to benefit. Moreover, by leveraging loss aversion, rebates are expected to generate a stronger behavioural response than equivalent financial rewards. The main objective of the Study on Incentives for Glaucoma Medication Adherence (SIGMA) is to test the VP approach relative to usual care (UC) in improving medication adherence. SIGMA is a randomized, controlled, open-label, single-centre superiority trial with two parallel arms. A total of 100 non-adherent (Morisky Medication Adherence Scale ≤6) glaucoma patients from the Singapore National Eye Centre are block-randomized (blocking factor: single versus multiple medications users) into the VP and UC arms in a 1:1 ratio. The treatment received by VP patients will be strictly identical to that received by UC patients, with the only exception being that VP patients can earn either a 50 % or 25 % rebate on their glaucoma-related healthcare costs conditional on being adherent on at least 90 % or 75 % of days as measured by a medication event monitoring system. Masking the arm allocation will be precluded by the behavioural nature of the intervention but blocking size will not be disclosed to protect concealment. The primary outcome is the mean change from baseline in percentage of adherent days at month 6. A day will be counted as adherent when the patients take all their medication(s) within the appropriate dosing windows. This trial will provide evidence on whether adherence-contingent rebates can improve medication adherence among non-adherent glaucoma patients, and more generally whether this approach represents a promising strategy to cost-effectively improve chronic disease management. NCT02271269 . Registered on 19 October 2014.

Direct and indirect links between parenting styles, self-concealment (secrets), impaired control over drinking and alcohol-related outcomes.

PubMed

Hartman, Jessica D; Patock-Peckham, Julie A; Corbin, William R; Gates, Jonathan R; Leeman, Robert F; Luk, Jeremy W; King, Kevin M

2015-01-01

Self-concealment reflects uncomfortable feelings, thoughts, and information people have about themselves that they avoid telling others (Larson & Chastain, 1990). According to Larson and Chastain (1990) these secrets range from the slightly embarrassing to the very distressing with an individual's most traumatic experiences often concealed. Parental attitudes including those involving self-disclosure are thought to be expressed in their choice of parenting style (Brand, Hatzinger, Beck, & Holsboer-Trachsler, 2009). The specific aim of this investigation was to examine the direct and indirect influences of parenting styles on self-concealment, impaired control over drinking (i.e. the inability to stop drinking when intended), alcohol use (quantity/frequency), and alcohol-related problems. A structural equation model with 419 (223 men, 196 women) university students was examined. Two and three path mediated effects were examined with the bias corrected bootstrap technique in Mplus. Having an authoritarian mother was directly linked to more self-concealment, while having an authoritative father was directly linked to less self-concealment. Higher levels of mother authoritarianism were indirectly linked to both increased alcohol use and alcohol-related problems through more self-concealment and more impaired control over drinking. Moreover, higher levels of father authoritativeness were indirectly linked to less alcohol use and alcohol-related problems through less self-concealment and less impaired control over drinking. These findings suggest that parenting styles influence vulnerabilities such as self-concealment in the impaired control over the drinking pathway to alcohol use and alcohol-related problems. Copyright © 2014 Elsevier Ltd. All rights reserved.

Disclosure and concealment of sexual orientation and the mental health of non-gay-identified, behaviorally bisexual men.

PubMed

Schrimshaw, Eric W; Siegel, Karolynn; Downing, Martin J; Parsons, Jeffrey T

2013-02-01

Although bisexual men report lower levels of mental health relative to gay men, few studies have examined the factors that contribute to bisexual men's mental health. Bisexual men are less likely to disclose, and more likely to conceal (i.e., a desire to hide), their sexual orientation than gay men. Theory suggests that this may adversely impact their mental health. This report examined the factors associated with disclosure and with concealment of sexual orientation, the association of disclosure and concealment with mental health, and the potential mediators (i.e., internalized homophobia, social support) of this association with mental health. An ethnically diverse sample of 203 non-gay-identified, behaviorally bisexual men who do not disclose their same-sex behavior to their female partners were recruited in New York City to complete a single set of self-report measures. Concealment was associated with higher income, a heterosexual identification, living with a wife or girlfriend, more frequent sex with women, and less frequent sex with men. Greater concealment, but not disclosure to friends and family, was significantly associated with lower levels of mental health. Multiple mediation analyses revealed that both internalized homophobia and general emotional support significantly mediated the association between concealment and mental health. The findings demonstrate that concealment and disclosure are independent constructs among bisexual men. Further, they suggest that interventions addressing concerns about concealment, emotional support, and internalized homophobia may be more beneficial for increasing the mental health of bisexual men than those focused on promoting disclosure.

Disclosure and Concealment of Sexual Orientation and the Mental Health of Non-Gay-Identified, Behaviorally-Bisexual Men

PubMed Central

Schrimshaw, Eric W.; Siegel, Karolynn; Downing, Martin J.; Parsons, Jeffrey T.

2013-01-01

Objective Although bisexual men report lower levels of mental health relative to gay men, few studies have examined the factors that contribute to bisexual men’s mental health. Bisexual men are less likely to disclose, and more likely to conceal (i.e., a desire to hide), their sexual orientation than gay men. Theory suggests that this may adversely impact their mental health. This report examined the factors associated with disclosure and with concealment of sexual orientation, the association of disclosure and concealment with mental health, and the potential mediators (i.e., internalized homophobia, social support) of this association with mental health. Method An ethnically-diverse sample of 203 non-gay-identified, behaviorally-bisexual men who do not disclose their same-sex behavior to their female partners were recruited in New York City to complete a single set of self-report measures. Results Concealment was associated with higher income, a heterosexual identification, living with a wife or girlfriend, more frequent sex with women, and less frequent sex with men. Greater concealment, but not disclosure to friends and family, was significantly associated with lower levels of mental health. Multiple mediation analyses revealed that both internalized homophobia and general emotional support significantly mediated the association between concealment and mental health. Conclusions The findings demonstrate that concealment and disclosure are independent constructs among bisexual men. Further, they suggest that interventions addressing concerns about concealment, emotional support, and internalized homophobia may be more beneficial for increasing the mental health of bisexual men than those focused on promoting disclosure. PMID:23276123

Geometry, structure, and concealed lithology of the San Rafael Basin, southeastern Arizona

USGS Publications Warehouse

Bultman, Mark W.

1999-01-01

The contiguous United States has been well explored for exposed conventional mineral deposits. Therefore, it is likely that many economically viable and strategically significant conventional undiscovered mineral deposits will be found in bedrock concealed beneath basin sediments. Mineral resource assessments must incorporate an understanding of the geometry, structure, and concealed lithology of basins in order to be accurate. This report presents an analysis of the basin geometry and structure of the San Rafael basin in southeastern Arizona. In addition, a new methodology for inferring concealed lithology is presented and applied in the San Rafael basin. Gravity data is used to model the geometry of the basin using recent models of sediment density vs. depth developed in the region. This modeling indicates that the basin has a maximum depth of approximately 1.05 km plus or minus 0.10 km. In the southern portion, the basin can be modeled as an asymmetric graben faulted on the western margin. The northern portion of the basin is structurally more complex and may have high angle faults on the western, northern, and eastern margin. Near-ground closely spaced Earth’s total intensity magnetic field data is used to locate concealed faults within the basin. This data is also used to infer lithology concealed by shallow basin sediments. Airborne Earth’s total intensity magnetic field data is used to help infer concealed lithology in deep portions of the basin. The product of integrating all data and interpretations is a map which presents the geometry of the basin, faults and contacts concealed by basin sediments, and an estimate of the bedrock lithology concealed by basin sediment. Based on basin geometry and concealed lithology, the San Rafael basin has a high potential for concealed mineral deposits on its western and northern margin. In particular, a newly discovered magnetic anomaly in the northern portion of the basin can be modeled as a granitic intrusion with highly altered margins and may represent a potential mineral resource target. Based on the permeability and porosity of upper basin fill found in nearby basins, the San Rafael basin may contain an aquifer up to 300 meters thick over a substantial area of the basin.

Trends in E & G Expenditure Allocations. Indicators of Recession or Increased Productivity?

ERIC Educational Resources Information Center

Minter, John

1992-01-01

A random sample of 300 financial officers at public and independent 4-year and public 2-year institutions reveal their projected fiscal 1992 year-end expenditures and 1992-93 budget allocations. Summarized in chart form are the findings on changes in growth rates on salary and wage allocations for a variety of institutional functions. (GLR)

Development and Validation of the Body Concealment Scale for Scleroderma.

PubMed

Jewett, Lisa R; Malcarne, Vanessa L; Kwakkenbos, Linda; Harcourt, Diana; Rumsey, Nichola; Körner, Annett; Steele, Russell J; Hudson, Marie; Baron, Murray; Haythornthwaite, Jennifer A; Heinberg, Leslie; Wigley, Fredrick M; Thombs, Brett D

2016-08-01

Body concealment is a component of social avoidance among people with visible differences from disfiguring conditions, including systemic sclerosis (SSc). The study objective was to develop a measure of body concealment related to avoidance behaviors in SSc. Initial items for the Body Concealment Scale for Scleroderma (BCSS) were selected using item analysis in a development sample of 93 American SSc patients. The factor structure of the BCSS was evaluated in 742 Canadian patients with single-factor, 2-factor, and bifactor confirmatory factor analysis models. Convergent and divergent validity were assessed by comparing the BCSS total score with the Brief-Satisfaction with Appearance Scale (Brief-SWAP) and measures of depressive symptoms and pain. A 2-factor model (Comparative Fit Index [CFI] 0.99, Tucker-Lewis Index [TLI] 0.98, Root Mean Square Error of Approximation [RMSEA] 0.08) fit substantially better than a 1-factor model (CFI 0.95, TLI 0.94, RMSEA 0.15) for the 9-item BCSS, but the Concealment with Clothing and Concealment of Hands factors were highly correlated (α = 0.79). The bifactor model (CFI 0.99, TLI 0.99, RMSEA 0.08) also fit well. In the bifactor model, the omega coefficient was high for the general factor (ω = 0.80), but low for the Concealment with Clothing (ω = 0.01) and Concealment of Hands (ω = 0.33) factors. The BCSS total score correlated more strongly with the Brief-SWAP Social Discomfort (r = 0.59) and Dissatisfaction with Appearance (r = 0.53) subscales than with measures of depressive symptoms and pain. The BCSS sum score is a valid indicator of body concealment in SSc that extends the concepts of body concealment and avoidance beyond the realms of body shape and weight to concerns of individuals with visible differences from SSc. © 2016, American College of Rheumatology.

Investigation of the structure and lithology of bedrock concealed by basin fill, using ground-based magnetic-field-profile data acquired in the San Rafael Basin, southeastern Arizona

USGS Publications Warehouse

Bultman, Mark W.

2013-01-01

Data on the Earth’s total-intensity magnetic field acquired near ground level and at measurement intervals as small as 1 m include information on the spatial distribution of nearsurface magnetic dipoles that in many cases are unique to a specific lithology. Such spatial information is expressed in the texture (physical appearance or characteristics) of the data at scales of hundreds of meters to kilometers. These magnetic textures are characterized by several descriptive statistics, their power spectrum, and their multifractal spectrum. On the basis of a graphical comparison and textural characterization, ground-based magnetic-field profile data can be used to estimate bedrock lithology concealed by as much as 100 m of basin fill in some cases, information that is especially important in assessing and exploring for concealed mineral deposits. I demonstrate that multifractal spectra of ground-based magnetic-field-profile data can be used to differentiate exposed lithologies and that the shape and position of the multifractal spectrum of the ground-based magnetic-field-profile of concealed lithologies can be matched to the upward-continued multifractal spectrum of an exposed lithology to help distinguish the concealed lithology. In addition, ground-based magnetic-field-profile data also detect minute differences in the magnetic susceptibility of rocks over small horizontal and vertical distances and so can be used for precise modeling of bedrock geometry and structure, even when that bedrock is concealed by 100 m or more of nonmagnetic basin fill. Such data contain valuable geologic information on the bedrock concealed by basin fill that may not be so visible in aeromagnetic data, including areas of hydrothermal alteration, faults, and other bedrock structures. Interpretation of these data in the San Rafael Basin, southeastern Arizona, has yielded results for estimating concealed lithologies, concealed structural geology, and a concealed potential mineral-resource target.

The methodological quality of animal research in critical care: the public face of science.

PubMed

Bara, Meredith; Joffe, Ari R

2014-01-01

Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals. All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were analyzed with descriptive statistics. Seventy-seven AR publications were reviewed. Our primary outcome (animal strain, sex, and weight or age described) was reported in 52 (68%; 95% confidence interval, 56% to 77%). Of the 77 publications, 47 (61%) reported randomization; of these, 3 (6%) reported allocation concealment, and 1 (2%) the randomization procedure. Of the 77 publications, 31 (40%) reported some type of blinding; of these, disease induction (2, 7%), intervention (7, 23%), and/or subjective outcomes (17, 55%) were blinded. A sample size calculation was reported in 4/77 (5%). Animal numbers were missing in the Methods section in 16 (21%) publications; when stated, the median was 32 (range 6 to 320; interquartile range, 21 to 70). Extra animals used were mentioned in the Results section in 31 (40%) publications; this number was unclear in 23 (74%), and >100 for 12 (16%). When reporting most outcomes, numbers with denominators were given in 35 (45%), with no unaccounted numbers in 24 (31%), and no animals excluded from analysis in 20 (26%). Most (49, 64%) studies reported >40, and another 19 (25%) reported 21 to 40 statistical comparisons. Internal validity limitations were discussed in 7 (9%), and external validity (to humans) discussed in 71 (92%), most with no (30, 42%) or only a vague (9, 13%) limitation to this external validity mentioned. The reported methodological quality of AR was poor. Unless the quality of AR significantly improves, the practice may be in serious jeopardy of losing public support.

The methodological quality of animal research in critical care: the public face of science

PubMed Central

2014-01-01

Background Animal research (AR) findings often do not translate to humans; one potential reason is the poor methodological quality of AR. We aimed to determine this quality of AR reported in critical care journals. Methods All AR published from January to June 2012 in three high-impact critical care journals were reviewed. A case report form and instruction manual with clear definitions were created, based on published recommendations, including the ARRIVE guidelines. Data were analyzed with descriptive statistics. Results Seventy-seven AR publications were reviewed. Our primary outcome (animal strain, sex, and weight or age described) was reported in 52 (68%; 95% confidence interval, 56% to 77%). Of the 77 publications, 47 (61%) reported randomization; of these, 3 (6%) reported allocation concealment, and 1 (2%) the randomization procedure. Of the 77 publications, 31 (40%) reported some type of blinding; of these, disease induction (2, 7%), intervention (7, 23%), and/or subjective outcomes (17, 55%) were blinded. A sample size calculation was reported in 4/77 (5%). Animal numbers were missing in the Methods section in 16 (21%) publications; when stated, the median was 32 (range 6 to 320; interquartile range, 21 to 70). Extra animals used were mentioned in the Results section in 31 (40%) publications; this number was unclear in 23 (74%), and >100 for 12 (16%). When reporting most outcomes, numbers with denominators were given in 35 (45%), with no unaccounted numbers in 24 (31%), and no animals excluded from analysis in 20 (26%). Most (49, 64%) studies reported >40, and another 19 (25%) reported 21 to 40 statistical comparisons. Internal validity limitations were discussed in 7 (9%), and external validity (to humans) discussed in 71 (92%), most with no (30, 42%) or only a vague (9, 13%) limitation to this external validity mentioned. Conclusions The reported methodological quality of AR was poor. Unless the quality of AR significantly improves, the practice may be in serious jeopardy of losing public support. PMID:25114829

Treatment Effect in Earlier Trials of Patients With Chronic Medical Conditions: A Meta-Epidemiologic Study.

PubMed

Alahdab, Fares; Farah, Wigdan; Almasri, Jehad; Barrionuevo, Patricia; Zaiem, Feras; Benkhadra, Raed; Asi, Noor; Alsawas, Mouaz; Pang, Yifan; Ahmed, Ahmed T; Rajjo, Tamim; Kanwar, Amrit; Benkhadra, Khalid; Razouki, Zayd; Murad, M Hassan; Wang, Zhen

2018-03-01

To determine whether the early trials in chronic medical conditions demonstrate an effect size that is larger than that in subsequent trials. We identified randomized controlled trials (RCTs) evaluating a drug or device in patients with chronic medical conditions through meta-analyses (MAs) published between January 1, 2007, and June 23, 2015, in the 10 general medical journals with highest impact factor. We estimated the prevalence of having the largest effect size or heterogeneity in the first 2 published trials. We evaluated the association of the exaggerated early effect with several a priori hypothesized explanatory variables. We included 70 MAs that had included a total of 930 trials (average of 13 [range, 5-48] RCTs per MA) with average follow-up of 24 (range, 1-168) months. The prevalence of the exaggerated early effect (ie, proportion of MAs with largest effect or heterogeneity in the first 2 trials) was 37%. These early trials had an effect size that was on average 2.67 times larger than the overall pooled effect size (ratio of relative effects, 2.67; 95% CI, 2.12-3.37). The presence of exaggerated effect was not significantly associated with trial size; number of events; length of follow-up; intervention duration; number of study sites; inpatient versus outpatient setting; funding source; stopping a trial early; adequacy of random sequence generation, allocation concealment, or blinding; loss to follow-up or the test for publication bias. Trials evaluating treatments of chronic medical conditions published early in the chain of evidence commonly demonstrate an exaggerated treatment effect compared with subsequent trials. At the present time, this phenomenon remains unpredictable. Considering the increasing morbidity and mortality of chronic medical conditions, decision makers should act on early evidence with caution. Copyright © 2017 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

The effectiveness of a physical activity stimulation programme for children with cerebral palsy on social participation, self-perception and quality of life: a randomized controlled trial.

PubMed

Van Wely, Leontien; Balemans, Astrid Cj; Becher, Jules G; Dallmeijer, Annet J

2014-10-01

To determine the effects of a six-month physical activity stimulation programme on social participation, self-perception and quality of life in children with cerebral palsy. Multicentre randomized controlled trial with concealed allocation, blinded assessments and intention-to-treat analysis. Paediatric physiotherapy practices, special schools for children with a disability, and the child's own home. Forty-nine children with spastic cerebral palsy (28 male), aged 7-13 years, able to walk with and without walking aids. The intervention group followed a six-month physical activity stimulation programme involving counselling through motivational interviewing, home-based physiotherapy and four months of fitness training. The control group continued regular paediatric physiotherapy. Outcomes included social participation in domestic life, social participation in recreation and leisure (Life-Habits for Children questionnaire and Children's Assessment of Participation and Enjoyment questionnaire), self-perception (Harter's Self-Perception Profile for Children) and parent-reported quality of life (Cerebral Palsy Quality of Life Questionnaire). Assessments were performed at baseline, at six months (except quality of life) and at twelve months. Intervention resulted in a positive effect on social participation in domestic life at twelve months (mean between-group difference = 0.9, 95% confidence interval (CI) = 0.1 to 1.7 [1-10 scale], P = 0.03), but not at six months. No significant effects were found for social participation in recreation and leisure, self-perception at six months and twelve months or for quality of life at twelve months. The combination of counselling, home-based physiotherapy and fitness training was not effective in improving social participation in recreation and leisure, self-perception or quality of life, but did show a potential for improving social participation in domestic life over the longer term. © The Author(s) 2013.

Cognitive Bias Modification Training During Inpatient Alcohol Detoxification Reduces Early Relapse: A Randomized Controlled Trial.

PubMed

Manning, Victoria; Staiger, Petra K; Hall, Kate; Garfield, Joshua B B; Flaks, Gabriella; Leung, Daniel; Hughes, Laura K; Lum, Jarrad A G; Lubman, Dan I; Verdejo-Garcia, Antonio

2016-09-01

Relapse is common in alcohol-dependent individuals and can be triggered by alcohol-related cues in the environment. It has been suggested that these individuals develop cognitive biases, in which cues automatically capture attention and elicit an approach action tendency that promotes alcohol seeking. The study aim was to examine whether cognitive bias modification (CBM) training targeting approach bias could be delivered during residential alcohol detoxification and improve treatment outcomes. Using a 2-group parallel-block (ratio 1:1) randomized controlled trial with allocation concealed to the outcome assessor, 83 alcohol-dependent inpatients received either 4 sessions of CBM training where participants were implicitly trained to make avoidance movements in response to pictures of alcoholic beverages and approach movements in response to pictures of nonalcoholic beverages, or 4 sessions of sham training (controls) delivered over 4 consecutive days during the 7-day detoxification program. The primary outcome measure was continuous abstinence at 2 weeks postdischarge. Secondary outcomes included time to relapse, frequency and quantity of alcohol consumption, and craving. Outcomes were assessed in a telephonic follow-up interview. Seventy-one (85%) participants were successfully followed up, of whom 61 completed all 4 training sessions. With an intention-to-treat approach, there was a trend for higher abstinence rates in the CBM group relative to controls (69 vs. 47%, p = 0.07); however, a per-protocol analysis revealed significantly higher abstinence rates among participants completing 4 sessions of CBM relative to controls (75 vs. 45%, p = 0.02). Craving score, time to relapse, mean drinking days, and mean standard drinks per drinking day did not differ significantly between the groups. This is the first trial demonstrating the feasibility of CBM delivered during alcohol detoxification and supports earlier research suggesting it may be a useful, low-cost adjunctive treatment to improve treatment outcomes for alcohol-dependent patients. Copyright © 2016 by the Research Society on Alcoholism.

Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes: a randomized controlled trial

PubMed Central

Wang, Philip S.; Simon, Gregory E.; Avorn, Jerry; Azocar, Francisca; Ludman, Evette J.; McCulloch, Joyce; Petukhova, Maria Z.; Kessler, Ronald C.

2010-01-01

Context Although guideline-concordant depression treatment is clearly effective, treatment often falls short of evidence-based recommendations. Organized depression care programs significantly improve treatment quality, but employer-purchasers have been slow to demand these programs based on lack of evidence for cost-effectiveness from their perspective. Objective To evaluate the effects of a depression outreach-treatment program on workplace outcomes of concern to employers. Design Randomized controlled trial with allocation concealment and blinded assessment of depression severity and work performance at 6 and 12 months. Setting and Participants Two-stage screening of employees covered by a managed behavioral health plan identified 604 with clinically significant depression (excluding those with lifetime bipolar disorder, substance disorder, recent mental health specialty care, or suicidality). Intervention A telephonic outreach and care management program encouraged workers to enter outpatient treatment (psychotherapy and/or antidepressant medication), monitored treatment quality-continuity, and attempted to improve treatment by giving recommendations to providers. Participants reluctant to enter treatment were offered a structured telephone cognitive-behavioral psychotherapy. Main Outcome Measures Depression severity (Quick Inventory of Depressive Symptomatology, QIDS-SR) and work performance (WHO Health and Productivity Questionnaire, HPQ, a validated self-report instrument assessing job retention, time missed from work, work performance, and critical workplace incidents). Results Combining data across 6-month and 12-month assessments, the intervention group had significantly lower QIDS-SR scores (1.4 relative-odds of recovery), significantly higher job retention (1.7 relative-odds), and significantly more hours worked among the employed (equivalent to an annualized effect of approximately 2.5 weeks of work) than usual care subjects. Conclusions A systematic program to identify depression and promote effective treatment significantly improves not only clinical outcomes but also workplace outcomes. The financial value of the latter to employers in terms of recovered hiring-training and salary costs suggests that many employers would experience a positive return on investment from outreach and enhanced treatment of depressed workers. PMID:17895456

Both hand position and movement direction modulate visual attention

PubMed Central

Festman, Yariv; Adam, Jos J.; Pratt, Jay; Fischer, Martin H.

2013-01-01

The current study explored effects of continuous hand motion on the allocation of visual attention. A concurrent paradigm was used to combine visually concealed continuous hand movements with an attentionally demanding letter discrimination task. The letter probe appeared contingent upon the moving right hand passing through one of six positions. Discrimination responses were then collected via a keyboard press with the static left hand. Both the right hand's position and its movement direction systematically contributed to participants' visual sensitivity. Discrimination performance increased substantially when the right hand was distant from, but moving toward the visual probe location (replicating the far-hand effect, Festman et al., 2013). However, this effect disappeared when the probe appeared close to the static left hand, supporting the view that static and dynamic features of both hands combine in modulating pragmatic maps of attention. PMID:24098288

Insulin and oral agents for managing cystic fibrosis-related diabetes.

PubMed

Onady, Gary M; Stolfi, Adrienne

2016-04-18

The Cystic Fibrosis Foundation recommends both short-term and long-acting insulin therapy when cystic fibrosis-related diabetes has been diagnosed. Diagnosis is based on: an elevated fasting blood glucose level greater than 6.94 mmol/liter (125 mg/deciliter); or oral glucose tolerance tests greater than 11.11 mmol/liter (200 mg/deciliter) at two hours; or symptomatic diabetes for random glucose levels greater than 11.11 mmol/liter (200 mg/deciliter); or glycated hemoglobin levels of at least 6.5%. To establish the effectiveness of insulin and oral agents for managing diabetes in people with cystic fibrosis in relation to blood sugar levels, lung function and weight management. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also handsearched abstracts from pulmonary symposia and the North American Cystic Fibrosis Conferences.Date of the most recent search of the Group's Cystic Fibrosis Trials Register: 18 February 2016. Randomized controlled trials comparing all methods of diabetes therapy in people with diagnosed cystic fibrosis-related diabetes. Two authors independently extracted data and assessed the risk of bias in the included studies. The searches identified 22 trials (34 references). Four trials (200 participants) are included: one short-term single-center trial (n = 7) comparing insulin with oral repaglinide and no medication in people with cystic fibrosis-related diabetes and normal fasting glucose; one long-term multicenter trial (n = 100, 74 of whom had cystic fibrosis-related diabetes) comparing insulin with oral repaglinide and placebo; one long-term multicenter trial (n = 73) comparing insulin with oral repaglinide; and one 12-week single-center trial (n = 20) comparing the long-acting insulin glargine to short-term neutral protamine Hagedorn insulin.Two trials with data for the comparison of insulin to placebo did not report any significant differences between groups for the primary outcomes of blood glucose levels, lung function and nutritional status. This was also true for the single trial with data for the comparison of repaglinide to placebo. Two trials (one lasting one year and one lasting two years) contributed data for the comparison of insulin versus repaglinide. There were no significant differences for the primary outcomes at any time point, except at one year (in the two-year trial) when the insulin group had significant improvement in z score for body mass index compared to the repaglinide group. The single trial comparing glargine to neutral protamine Hagedorn insulin also did not report any significant differences in the review's primary outcomes. A few cases of hypoglycemia were seen in three out of the four trials (none in the longest trial), but these events resolved without further treatment.There was an unclear risk of bias from randomization and allocation concealment in two of the four included trials as the authors did not report any details; in the remaining two studies details for randomization led to a low risk of bias, but only one had sufficient details on allocation concealment to allow a low risk judgement, the second was unclear. There was a high risk from blinding for all trials (except for the comparison of oral repaglinide versus placebo) due to the nature of the interventions. Complete data for all outcomes were not available from any trial leading to a high risk of reporting bias. The amounts of insulin and repaglinide administered were not comparable and this may lead to bias in the results. None of the included trials were powered to show a significant improvement in lung function. This review has not found any significant conclusive evidence that long-acting insulins, short-acting insulins or oral hypoglycemic agents have a distinct advantage over one another in controlling hyperglycemia or clinical outcomes associated with cystic fibrosis-related diabetes. While some cystic fibrosis centers use oral medications to help control diabetes, the Cystic Fibrosis Foundation (USA) clinical practice guidelines support the use of insulin therapy and this remains the most widely-used treatment method. Randomized controlled trials specifically related to controlling diabetes with this impact on the course of pulmonary disease process in cystic fibrosis continue to be a high priority.There is no demonstrated advantage yet established for using oral hypoglycemic agents over insulin, and further trials need to be evaluated to establish whether there is clear benefit for using hypoglycemic agents. Agents that potentiate insulin action, especially agents with additional anti-inflammatory potential should be further investigated to see if there may be a clinical advantage to adding these medications to insulin as adjuvant therapy.

Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial

PubMed Central

2012-01-01

Background Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic. Methods/design The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014. Discussion This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease. Trial registration ClinicalTrials.gov Identifier: NCT01149590 PMID:23036114

Carnitine for fatigue in multiple sclerosis.

PubMed

Tejani, Aaron M; Wasdell, Michael; Spiwak, Rae; Rowell, Greg; Nathwani, Shabita

2010-02-17

Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. A literature search was performed using Cochrane MS Group Trials Register (21 May 2009), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2009, issue 2, MEDLINE (PubMed) (1966-21 May 2009), EMBASE (1974-21 May 2009). Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults with a clinical diagnosis of fatigue associated with multiple sclerosis were included. Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer however this was not necessary. The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. The search identified one randomized cross-over trial. In this study patients were exposed to both acetyl L-carnitine (ALCAR(tm)) 2 grams daily and amantadine 200 mg daily in adult patients with relapsing-remitting and secondary progressive MS. The effects of carnitine on fatigue are not clear based on the one included crossover RCT. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55. Mortality, serious adverse events, total adverse events, and quality of life were not reported. There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators.

Concealed object segmentation and three-dimensional localization with passive millimeter-wave imaging

NASA Astrophysics Data System (ADS)

Yeom, Seokwon

2013-05-01

Millimeter waves imaging draws increasing attention in security applications for weapon detection under clothing. In this paper, concealed object segmentation and three-dimensional localization schemes are reviewed. A concealed object is segmented by the k-means algorithm. A feature-based stereo-matching method estimates the longitudinal distance of the concealed object. The distance is estimated by the discrepancy between the corresponding centers of the segmented objects. Experimental results are provided with the analysis of the depth resolution.

Guilt, censure, and concealment of active smoking status among cancer patients and family members after diagnosis: a nationwide study.

PubMed

Shin, Dong Wook; Park, Jong Hyock; Kim, So Young; Park, Eal Whan; Yang, Hyung Kook; Ahn, Eunmi; Park, Seon Mee; Lee, Young Joon; Lim, Myong Cheol; Seo, Hong Gwan

2014-05-01

We aimed to identify the prevalence of feelings of guilt, censure, and concealment of smoking status among cancer patients and their family members who continued to smoke after the patient's diagnosis. Among 990 patient-family member dyads, 45 patients and 173 family members who continued to smoke for at least 1 month after the patients' diagnoses were administered questions examining feelings of guilt, censure, and smoking concealment. Most patients who continued to smoke reported experiencing feelings of guilt toward their families (75.6%) and censure from their family members (77.8%), and many concealed their smoking from their family members (44.4%) or healthcare professionals (46.7%). Family members who continued to smoke also reported feelings of guilt with respect to the patient (63.6%) and that the patient was critical of them (68.9%), and many concealed their smoking from the patient (28.5%) or healthcare professionals (9.3%). Patients' feeling of guilt was associated with concealment of smoking from family members (55.9% vs. 10.0%) or health care professionals (55.9% vs. 20.0%). Family members who reported feeling guilty (36.5% vs. 16.3%) or censured (34.5% vs. 16.7%) were more likely to conceal smoking from patients. Many patients and family members continue to smoke following cancer diagnosis, and the majority of them experience feelings of guilt and censure, which can lead to the concealment of smoking status from families or health care professionals. Feelings of guilt, censure, and concealment of smoking should be considered in the development and implementation of smoking cessation programs for cancer patients and family members. Copyright © 2013 John Wiley & Sons, Ltd.

Two-step egg introduction for prevention of egg allergy in high-risk infants with eczema (PETIT): a randomised, double-blind, placebo-controlled trial.

PubMed

Natsume, Osamu; Kabashima, Shigenori; Nakazato, Junko; Yamamoto-Hanada, Kiwako; Narita, Masami; Kondo, Mai; Saito, Mayako; Kishino, Ai; Takimoto, Tetsuya; Inoue, Eisuke; Tang, Julian; Kido, Hiroshi; Wong, Gary W K; Matsumoto, Kenji; Saito, Hirohisa; Ohya, Yukihiro

2017-01-21

Evidence is accumulating that early consumption is more beneficial than is delayed introduction as a strategy for primary prevention of food allergy. However, allergic reactions caused by early introduction of such solid foods have been a problematic issue. We investigated whether or not early stepwise introduction of eggs to infants with eczema combined with optimal eczema treatment would prevent egg allergy at 1 year of age. In this randomised, double-blind, placebo-controlled trial, we enrolled infants 4-5 months of age with eczema from two centres in Japan. Exclusion criteria were being born before 37 weeks of gestational age, experience of ingestion of hen's eggs or egg products, history of immediate allergic reaction to hen's eggs, history of non-immediate allergic reaction to a particular type of food, and complications of any severe disease. Infants were randomly assigned (block size of four; stratified by institution and sex) to early introduction of egg or placebo (1:1). Participants in the egg group consumed orally 50 mg of heated egg powder per day from 6 months to 9 months of age and 250 mg per day thereafter until 12 months of age. We aggressively treated participants' eczema at entry and maintained control without exacerbations throughout the intervention period. Participants and physicians were masked to assignment, and allocation was concealed. The primary outcome was the proportion of participants with hen's egg allergy confirmed by open oral food challenges at 12 months of age, assessed blindly by standardised methods, in all randomly allocated participants who received the intervention. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN000008673. Between Sept 18, 2012, and Feb 13, 2015, we randomly allocated 147 participants (73 [50%] to the egg group and 74 [50%] to the placebo group). This trial was terminated on the basis of the results of the scheduled interim analysis of 100 participants, which showed a significant difference between the two groups (four [9%] of 47 participants had an egg allergy in the egg group vs 18 [38%] of 47 in the placebo group; risk ratio 0·222 [95% CI 0·081-0·607]; p=0·0012). In the primary analysis population, five (8%) of 60 participants had an egg allergy in the egg group compared with 23 (38%) of 61 in the placebo group (risk ratio 0·221 [0·090-0·543]; p=0·0001). The only difference in adverse events between groups was admissions to hospital (six [10%] of 60 in the egg group vs none in the placebo group; p=0·022). 19 acute events occurred in nine (15%) participants in the egg group versus 14 events in 11 (18%) participants in the placebo group after intake of the trial powder. Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent hen's egg allergy in high-risk infants. In this study, we developed a practical approach to overcome the second wave of the allergic epidemic caused by food allergy. Ministry of Health, Labour and Welfare, and National Centre for Child Health and Development, Japan. Copyright © 2017 Elsevier Ltd. All rights reserved.

Male-female differences in households' resource allocation and decision to seek healthcare in south-eastern Nigeria: Results from a mixed methods study.

PubMed

Onah, Michael Nnachebe; Horton, Susan

2018-05-01

Ability to influence household decision-making has been shown to increase with improved social capital and power and is linked to better access to household financial resources and other services outside the household including healthcare. To examine the male-female differences in household custody of financial resources, decision-making, and type of healthcare utilised, we used a mixed methods approach of cross-sectional household surveys and focus-group discussions (FGDs). Data was collected between 10 January-28 February 2011. We analyzed a sample of 411 households and a sub-sample of 223 households with a currently married head. We conducted six single-sex FGDs in 3 communities (1 urban, 2 rural) among a random sub-sample of participants in the survey. We performed univariate, bivariate, and logistic regression analyses with a 95% confidence interval. For the qualitative data, we performed thematic analysis where broad themes relevant to the research objective were abstracted. In all households and in those with a married head, sick male members were less likely to forgo healthcare (aOR all 0.87, 95% CI 0.80-0.90; aOR married 0.52, 95% CI 0.18-0.83) and more likely to utilise formal healthcare relative to female sick members (aOR all 3.36, 95% CI 3.20-3.87; aOR married 19.50, 95% CI 9.62-39.52). Formal healthcare providers are medically trained while informal providers are untrained vendors that dispense medications for profit. There were more reports of sole custody of household resources among men within households with married heads. Joint decision-making on healthcare expenditure improved women's access to healthcare but is not reflective of unhindered access to household financial resources. Qualitatively, women spoke of seeking permission from male household head before expenditure was incurred, while male heads spoke of concealing household financial resources from their spouse. Gender constructs and male-female differences have important effects on household resource allocation and healthcare utilisation. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.

PubMed

Camenzind, Edoardo; Wijns, William; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P; Boersma, Eric; Vranckx, Pascal; McFadden, Eugene; Serruys, Patrick W; O'Neil, William W; Jorissen, Brenda; Van Leeuwen, Frank; Steg, Ph Gabriel

2012-10-20

We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. Medtronic, Inc. Copyright © 2012 Elsevier Ltd. All rights reserved.

Cervical joint position sense in neck pain. Immediate effects of muscle vibration versus mental training interventions: a RCT.

PubMed

Beinert, K; Preiss, S; Huber, M; Taube, W

2015-12-01

Impaired cervical joint position sense is a feature of chronic neck pain and is commonly argued to rely on abnormal cervical input. If true, muscle vibration, altering afferent input, but not mental interventions, should have an effect on head repositioning acuity and neck pain perception. The aim of the present study was to determine the short-term effects of neck muscle vibration, motor imagery, and action observation on cervical joint position sense and pressure pain threshold in people with chronic neck pain. Forty-five blinded participants with neck pain received concealed allocation and were randomized in three treatment groups. A blinded assessor performed pre- and post-test measurement. Patients were recruited from secondary outpatient clinics in the southwest of Germany. Chronic, non specific neck pain patients without arm pain were recruited for this study. A single intervention session of 5 minutes was delivered to each blinded participant. Patients were either allocated to one of the following three interventions: (1) neck muscle vibration; (2) motor imagery; (3) action observation. Primary outcomes were cervical joint position sense acuity and pressure pain threshold. Repeated measures ANOVAs were used to evaluate differences between groups and subjects. Repositioning acuity displayed significant time effects for vibration, motor imagery, and action observation (all P<0.05), but revealed no time*group effect. Pressure pain threshold demonstrated a time*group effect (P=0.042) as only vibration significantly increased pressure pain threshold (P=0.01). Although motor imagery and action observation did not modulate proprioceptive, afferent input, they nevertheless improved cervical joint position sense acuity. This indicates that, against the common opinion, changes in proprioceptive input are not prerequisite to improve joint repositioning performance. However, the short-term applications of these cognitive treatments had no effect on pressure pain thresholds, whereas vibration reduced pressure pain thresholds. This implies different underlying mechanisms after vibration and mental training. Mental interventions were effective in improving cervical joint position sense and are easy to integrate in rehabilitation regimes. Neck muscle vibration is effective in improving cervical joint position sense and pressure pain thresholds within 5 minutes of application.

The Effectiveness of Mobile-Health Technologies to Improve Health Care Service Delivery Processes: A Systematic Review and Meta-Analysis

PubMed Central

Free, Caroline; Phillips, Gemma; Watson, Louise; Galli, Leandro; Felix, Lambert; Edwards, Phil; Patel, Vikram; Haines, Andy

2013-01-01

Background Mobile health interventions could have beneficial effects on health care delivery processes. We aimed to conduct a systematic review of controlled trials of mobile technology interventions to improve health care delivery processes. Methods and Findings We searched for all controlled trials of mobile technology based health interventions using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990–Sept 2010). Two authors independently extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and we used random effects meta-analysis to give pooled estimates. We identified 42 trials. None of the trials had low risk of bias. Seven trials of health care provider support reported 25 outcomes regarding appropriate disease management, of which 11 showed statistically significant benefits. One trial reported a statistically significant improvement in nurse/surgeon communication using mobile phones. Two trials reported statistically significant reductions in correct diagnoses using mobile technology photos compared to gold standard. The pooled effect on appointment attendance using text message (short message service or SMS) reminders versus no reminder was increased, with a relative risk (RR) of 1.06 (95% CI 1.05–1.07, I 2 = 6%). The pooled effects on the number of cancelled appointments was not significantly increased RR 1.08 (95% CI 0.89–1.30). There was no difference in attendance using SMS reminders versus other reminders (RR 0.98, 95% CI 0.94–1.02, respectively). To address the limitation of the older search, we also reviewed more recent literature. Conclusions The results for health care provider support interventions on diagnosis and management outcomes are generally consistent with modest benefits. Trials using mobile technology-based photos reported reductions in correct diagnoses when compared to the gold standard. SMS appointment reminders have modest benefits and may be appropriate for implementation. High quality trials measuring clinical outcomes are needed. Please see later in the article for the Editors' Summary PMID:23458994

A study protocol of a randomised controlled trial to investigate if a community based strength training programme improves work task performance in young adults with Down syndrome.

PubMed

Shields, Nora; Taylor, Nicholas F; Fernhall, Bo

2010-03-25

Muscle strength is important for young people with Down syndrome as they make the transition to adulthood, because their workplace activities typically emphasise physical rather than cognitive skills. Muscle strength is reduced up to 50% in people with Down syndrome compared to their peers without disability. Progressive resistance training improves muscle strength and endurance in people with Down syndrome. However, there is no evidence on whether it has an effect on work task performance or physical activity levels. The aim of this study is to investigate if a student-led community-based progressive resistance training programme can improve these outcomes in adolescents and young adults with Down syndrome. A randomised controlled trial will compare progressive resistance training with a control group undertaking a social programme. Seventy adolescents and young adults with Down syndrome aged 14-22 years and mild to moderate intellectual disability will be randomly allocated to the intervention or control group using a concealed method. The intervention group will complete a 10-week, twice a week, student-led progressive resistance training programme at a local community gymnasium. The student mentors will be undergraduate physiotherapy students. The control group will complete an arts/social programme with a student mentor once a week for 90 minutes also for 10 weeks to control for the social aspect of the intervention. Work task performance (box stacking, pail carry), muscle strength (1 repetition maximum for chest and leg press) and physical activity (frequency, duration, intensity over 7-days) will be assessed at baseline (Week 0), following the intervention (Week 11), and at 3 months post intervention (Week 24) by an assessor blind to group allocation. Data will be analysed using ANCOVA with baseline measures as covariates. This paper outlines the study protocol for a randomised controlled trial on the effects of progressive resistance training on work task performance and physical activity for adolescents and young adults with Down syndrome. The intervention addresses the impairment of muscle weakness which may improve work task performance and help to increase physical activity levels. Australian New Zealand Clinical Trials Registry ACTRN12609000938202.

The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis.

PubMed

Free, Caroline; Phillips, Gemma; Watson, Louise; Galli, Leandro; Felix, Lambert; Edwards, Phil; Patel, Vikram; Haines, Andy

2013-01-01

Mobile health interventions could have beneficial effects on health care delivery processes. We aimed to conduct a systematic review of controlled trials of mobile technology interventions to improve health care delivery processes. We searched for all controlled trials of mobile technology based health interventions using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990-Sept 2010). Two authors independently extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and we used random effects meta-analysis to give pooled estimates. We identified 42 trials. None of the trials had low risk of bias. Seven trials of health care provider support reported 25 outcomes regarding appropriate disease management, of which 11 showed statistically significant benefits. One trial reported a statistically significant improvement in nurse/surgeon communication using mobile phones. Two trials reported statistically significant reductions in correct diagnoses using mobile technology photos compared to gold standard. The pooled effect on appointment attendance using text message (short message service or SMS) reminders versus no reminder was increased, with a relative risk (RR) of 1.06 (95% CI 1.05-1.07, I(2) = 6%). The pooled effects on the number of cancelled appointments was not significantly increased RR 1.08 (95% CI 0.89-1.30). There was no difference in attendance using SMS reminders versus other reminders (RR 0.98, 95% CI 0.94-1.02, respectively). To address the limitation of the older search, we also reviewed more recent literature. The results for health care provider support interventions on diagnosis and management outcomes are generally consistent with modest benefits. Trials using mobile technology-based photos reported reductions in correct diagnoses when compared to the gold standard. SMS appointment reminders have modest benefits and may be appropriate for implementation. High quality trials measuring clinical outcomes are needed. Please see later in the article for the Editors' Summary.

The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review.

PubMed

Free, Caroline; Phillips, Gemma; Galli, Leandro; Watson, Louise; Felix, Lambert; Edwards, Phil; Patel, Vikram; Haines, Andy

2013-01-01

Mobile technologies could be a powerful media for providing individual level support to health care consumers. We conducted a systematic review to assess the effectiveness of mobile technology interventions delivered to health care consumers. We searched for all controlled trials of mobile technology-based health interventions delivered to health care consumers using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990-Sept 2010). Two authors extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and used random effects meta-analysis. We identified 75 trials. Fifty-nine trials investigated the use of mobile technologies to improve disease management and 26 trials investigated their use to change health behaviours. Nearly all trials were conducted in high-income countries. Four trials had a low risk of bias. Two trials of disease management had low risk of bias; in one, antiretroviral (ART) adherence, use of text messages reduced high viral load (>400 copies), with a relative risk (RR) of 0.85 (95% CI 0.72-0.99), but no statistically significant benefit on mortality (RR 0.79 [95% CI 0.47-1.32]). In a second, a PDA based intervention increased scores for perceived self care agency in lung transplant patients. Two trials of health behaviour management had low risk of bias. The pooled effect of text messaging smoking cessation support on biochemically verified smoking cessation was (RR 2.16 [95% CI 1.77-2.62]). Interventions for other conditions showed suggestive benefits in some cases, but the results were not consistent. No evidence of publication bias was demonstrated on visual or statistical examination of the funnel plots for either disease management or health behaviours. To address the limitation of the older search, we also reviewed more recent literature. Text messaging interventions increased adherence to ART and smoking cessation and should be considered for inclusion in services. Although there is suggestive evidence of benefit in some other areas, high quality adequately powered trials of optimised interventions are required to evaluate effects on objective outcomes.

Management of a concealable stigmatized identity: A qualitative study of concealment, disclosure and role flexing among young, resilient sexual and gender minority individuals

PubMed Central

Bry, Laura Jane; Mustanski, Brian; Garofalo, Robert; Burns, Michelle Nicole

2017-01-01

Disclosure of a sexual or gender minority status has been associated with both positive and negative effects on wellbeing. Few studies have explored the disclosure and concealment process in young people. Interviews were conducted with 10 sexual and/or gender minority individuals, aged 18–22 years, of male birth sex. Data were analyzed qualitatively, yielding determinants and effects of disclosure and concealment. Determinants of disclosure included holding positive attitudes about one’s identity and an implicit devaluation of acceptance by society. Coming out was shown to have both positive and negative effects on communication and social support, and was associated with both increases and decreases in experiences of stigma. Determinants of concealment included lack of comfort with one’s identity and various motivations to avoid discrimination. Concealment was also related to hypervigilance and unique strategies of accessing social support. Results are discussed in light of their clinical implications. PMID:27633070

A Qualitative Study Examining Experiences and Dilemmas in Concealment and Disclosure of People Living With Serious Mental Illness.

PubMed

Bril-Barniv, Shani; Moran, Galia S; Naaman, Adi; Roe, David; Karnieli-Miller, Orit

2017-03-01

People with mental illnesses face the dilemma of whether to disclose or conceal their diagnosis, but this dilemma was scarcely researched. To gain in-depth understanding of this dilemma, we interviewed 29 individuals with mental illnesses: 16 with major depression/bipolar disorders and 13 with schizophrenia. Using a phenomenological design, we analyzed individuals' experiences, decision-making processes, and views of gains and costs regarding concealment and disclosure of mental illness. We found that participants employed both positive and negative disclosure/concealment practices. Positive practices included enhancing personal recovery, community integration, and/or supporting others. Negative practices occurred in forced, uncontrolled situations. We also identified various influencing factors, including familial norms of sharing, accumulated experiences with disclosure, and ascribed meaning to diagnosis. Based on these findings, we deepen the understanding about decision-making processes and the consequences of disclosing or concealing mental illness. We discuss how these finding can help consumers explore potential benefits and disadvantages of mental illness disclosure/concealment occurrences.

Physician Beliefs about Physical and Mental Competency of Patients Applying for Concealed Weapon Permits.

PubMed

Goldstein, Adam O; Viera, Anthony J; Pierson, John; Barnhouse, Kathy K; Tulsky, James A; Richman, Barak D

2015-06-01

Law enforcement officials have asked health care providers to evaluate patient applications for concealed weapon permits. The current study was designed to examine physician beliefs regarding competency to carry a concealed weapon for patients with specific physical and mental conditions. Among 222 North Carolina physicians who participated in this survey (40% response rate), large variation and uncertainty existed for determining competency. Physicians most frequently chose mild dementia, post-traumatic stress disorder, and recent depression as conditions that would render a patient not competent to carry a concealed weapon. Male physicians and those owning a gun were more likely to deem a patient competent. Almost a third of physicians were unsure about competence for most conditions. Physicians asked to assess competency of patients to carry a concealed weapon have quite disparate views on competency and little confidence in their decisions. If physicians are expected to assess patient competence to carry a concealed weapon, more objective criteria and training are needed. Copyright © 2015 John Wiley & Sons, Ltd.

Management of a Concealable Stigmatized Identity: A Qualitative Study of Concealment, Disclosure, and Role Flexing Among Young, Resilient Sexual and Gender Minority Individuals.

PubMed

Bry, Laura Jane; Mustanski, Brian; Garofalo, Robert; Burns, Michelle Nicole

2017-01-01

Disclosure of a sexual or gender minority status has been associated with both positive and negative effects on wellbeing. Few studies have explored the disclosure and concealment process in young people. Interviews were conducted with 10 sexual and/or gender minority individuals, aged 18-22 years, of male birth sex. Data were analyzed qualitatively, yielding determinants and effects of disclosure and concealment. Determinants of disclosure included holding positive attitudes about one's identity and an implicit devaluation of acceptance by society. Coming out was shown to have both positive and negative effects on communication and social support and was associated with both increases and decreases in experiences of stigma. Determinants of concealment included lack of comfort with one's identity and various motivations to avoid discrimination. Concealment was also related to hypervigilance and unique strategies of accessing social support. Results are discussed in light of their clinical implications.

Optimizing Utilization of Detectors

DTIC Science & Technology

2016-03-01

provide a quantifiable process to determine how much time should be allocated to each task sharing the same asset . This optimized expected time... allocation is calculated by numerical analysis and Monte Carlo simulation. Numerical analysis determines the expectation by involving an integral and...determines the optimum time allocation of the asset by repeatedly running experiments to approximate the expectation of the random variables. This

Evaluation of the procedure 1A component of the 1980 US/Canada wheat and barley exploratory experiment

NASA Technical Reports Server (NTRS)

Chapman, G. M. (Principal Investigator); Carnes, J. G.

1981-01-01

Several techniques which use clusters generated by a new clustering algorithm, CLASSY, are proposed as alternatives to random sampling to obtain greater precision in crop proportion estimation: (1) Proportional Allocation/relative count estimator (PA/RCE) uses proportional allocation of dots to clusters on the basis of cluster size and a relative count cluster level estimate; (2) Proportional Allocation/Bayes Estimator (PA/BE) uses proportional allocation of dots to clusters and a Bayesian cluster-level estimate; and (3) Bayes Sequential Allocation/Bayesian Estimator (BSA/BE) uses sequential allocation of dots to clusters and a Bayesian cluster level estimate. Clustering in an effective method in making proportion estimates. It is estimated that, to obtain the same precision with random sampling as obtained by the proportional sampling of 50 dots with an unbiased estimator, samples of 85 or 166 would need to be taken if dot sets with AI labels (integrated procedure) or ground truth labels, respectively were input. Dot reallocation provides dot sets that are unbiased. It is recommended that these proportion estimation techniques are maintained, particularly the PA/BE because it provides the greatest precision.

Exercise in children with joint hypermobility syndrome and knee pain: a randomised controlled trial comparing exercise into hypermobile versus neutral knee extension

PubMed Central

2013-01-01

Background Knee pain in children with Joint Hypermobility Syndrome (JHS) is traditionally managed with exercise, however the supporting evidence for this is scarce. No trial has previously examined whether exercising to neutral or into the hypermobile range affects outcomes. This study aimed to (i) determine if a physiotherapist-prescribed exercise programme focused on knee joint strength and control is effective in reducing knee pain in children with JHS compared to no treatment, and (ii) whether the range in which these exercises are performed affects outcomes. Methods A prospective, parallel-group, randomised controlled trial conducted in a tertiary hospital in Sydney, Australia compared an 8 week exercise programme performed into either the full hypermobile range or only to neutral knee extension, following a minimum 2 week baseline period without treatment. Randomisation was computer-generated, with allocation concealed by sequentially numbered opaque sealed envelopes. Knee pain was the primary outcome. Quality of life, thigh muscle strength, and function were also measured at (i) initial assessment, (ii) following the baseline period and (iii) post treatment. Assessors were blinded to the participants’ treatment allocation and participants blinded to the difference in the treatments. Results Children with JHS and knee pain (n=26) aged 7-16 years were randomly assigned to the hypermobile (n=12) or neutral (n=14) treatment group. Significant improvements in child-reported maximal knee pain were found following treatment, regardless of group allocation with a mean 14.5 mm reduction on the visual analogue scale (95% CI 5.2 – 23.8 mm, p=0.003). Significant differences between treatment groups were noted for parent-reported overall psychosocial health (p=0.009), specifically self-esteem (p=0.034), mental health (p=0.001) and behaviour (p=0.019), in favour of exercising into the hypermobile range (n=11) compared to neutral only (n=14). Conversely, parent-reported overall physical health significantly favoured exercising only to neutral (p=0.037). No other differences were found between groups and no adverse events occurred. Conclusions Parents perceive improved child psychosocial health when children exercise into the hypermobile range, while exercising to neutral only is perceived to favour the child’s physical health. A physiotherapist prescribed, supervised, individualised and progressed exercise programme effectively reduces knee pain in children with JHS. Trial registration Australia & New Zealand Clinical Trials Registry; ACTRN12606000109505. PMID:23941143

Combining rigour with relevance: a novel methodology for testing Chinese herbal medicine.

PubMed

Flower, Andrew; Lewith, George; Little, Paul

2011-03-24

There is a need to develop an evidence base for Chinese herbal medicine (CHM) that is both rigorous and reflective of good practice. This paper proposes a novel methodology to test individualised herbal decoctions using a randomised, double blinded, placebo controlled clinical trial. A feasibility study was conducted to explore the role of CHM in the treatment of endometriosis. Herbal formulae were pre-cooked and dispensed as individual doses in sealed plastic sachets. This permitted the development and testing of a plausible placebo decoction. Participants were randomised at a distant pharmacy to receive either an individualised herbal prescription or a placebo. The trial met the predetermined criteria for good practice. Neither the participants nor the practitioner-researcher could reliably identify group allocation. Of the 28 women who completed the trial, in the placebo group (n=15) 3 women (20%) correctly guessed they were on placebo, 8 (53%) thought they were on herbs and 4 (27%) did not know which group they had been allocated to. In the active group (n=13) 2 (15%) though they were on placebo, 8 (62%) thought they were on herbs and 3 (23%) did not know. Randomisation, double blinding and allocation concealment were successful and the study model appeared to be feasible and effective. It is now possible to subject CHM to rigorous scientific scrutiny without compromising model validity. Improvement in the design of the placebo using food colourings and flavourings instead of dried food will help guarantee the therapeutic inertia of the placebo decoction. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Self-Concealment Mediates the Relationship Between Perfectionism and Attitudes Toward Seeking Psychological Help Among Adolescents.

PubMed

Abdollahi, Abbas; Hosseinian, Simin; Beh-Pajooh, Ahmad; Carlbring, Per

2017-01-01

One of the biggest barriers in treating adolescents with mental health problems is their refusing to seek psychological help. This study was designed to examine the relationships between two forms of perfectionism, self-concealment and attitudes toward seeking psychological help and to test the mediating role of self-concealment in the relationship between perfectionism and attitudes toward seeking psychological help among Malaysian high school students. The participants were 475 Malaysian high school students from four high schools in Kuala Lumpur, Malaysia. Structural equation modelling results indicated that high school students with high levels of socially prescribed perfectionism, high levels of self-concealment, and low levels of self-oriented perfectionism reported negative attitudes toward seeking psychological help. Bootstrapping analysis showed that self-concealment emerged as a significant, full mediator in the link between socially prescribed perfectionism and attitudes toward seeking psychological help. Moderated mediation analysis also examined whether the results generalized across men and women. The results revealed that male students with socially prescribed perfectionism are more likely to engage in self-concealment, which in turn, leads to negative attitudes toward seeking psychological help more than their female counterparts. The results suggested that students high in socially prescribed perfectionism were more likely to engage in self-concealment and be less inclined to seek psychological help.

Quality of reporting in infertility journals.

PubMed

Glujovsky, Demian; Boggino, Carolina; Riestra, Barbara; Coscia, Andrea; Sueldo, Carlos E; Ciapponi, Agustín

2015-01-01

To evaluate whether fertility and top gynecology journals indexed in PubMed require the use of reporting guidelines and to identify the percentage of randomized controlled trials (RCTs) published in 2013 that were written following CONSORT guidelines in the top four fertility journals (by their highest impact factor). Cross-sectional study evaluating instructions for authors and RCTs published in fertility journals. Academic institution. None. None. Proportion of instruction-for-authors documents that suggested or required the use of reporting guidelines, and proportion of RCTs published in 2013 that accomplished the CONSORT checklist. In 47% (16/34) of the journals one or more reporting guidelines were mentioned in the instructions for authors' documents. PRISMA and CONSORT were the most commonly mentioned reporting guidelines. None of the analyzed RCTs completed the 25 items of CONSORT guideline. Sequence generation or allocation concealment was not described in 69% of the studies. One-third of the journals did not publish a flowchart, 72% did not show relative and absolute size-effect measures, and 42% did not use measures of imprecision. In the summaries, 42% did not discuss the limitations of the study and 78% did not mention the generalizability of the results. Less than half of the analyzed peer-reviewed journals request the authors to use reporting guidelines. Nevertheless, among the top fertility and gynecology journals, reporting guidelines are widely mentioned. Overall, accomplishment of CONSORT items was suboptimal. Editorial boards, reviewers, and authors should join efforts to improve the quality of reporting. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

The impact of advanced nurse practitioners on patient outcomes in chronic kidney disease: A systematic review.

PubMed

McCrory, Geraldine; Patton, Declan; Moore, Zena; O'Connor, Tom; Nugent, Linda

2018-06-11

Management of individuals with chronic kidney disease (CKD) requires a collaborative approach. Nurses have diversified their skills to take on roles which have been traditionally physician-led. The impact of such roles, mainly that of the advanced nurse practitioner (ANP), has not been previously assessed using a systematic approach. The aim of this systematic review (SR) was to determine the impact of the addition of an ANP on patient outcomes in adults with CKD. A SR, following the guidance of PRISMA was undertaken. Population: adults with CKD. ANP. Databases searched included The Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Embase and Medline. Outcome measures were blood pressure (BP), lipids, haemoglobin A1c (HbA1c), phosphate and parathormone (PTH) measures and recommended medication use. Four studies met the inclusion criteria. All possessed external validity and demonstrated low risk for random sequence generation and allocation concealment but were at high risk of performance bias and detection bias. The addition of an ANP resulted in the superior management of BP in all studies. Three studies reported improved control of low-density lipoprotein (LDL) and PTH. One study reported greater achievement of phosphate control. Glycaemic control was equal in both groups. All studies reported higher rates of recommended medication use. The addition of an ANP is superior or equal to the usual care models for the management of BP, LDL, PTH and glycaemic control in adults with CKD. © 2018 European Dialysis and Transplant Nurses Association/European Renal Care Association.

Effect of a self-instructional module on the child rearing knowledge and practice of women with epilepsy.

PubMed

Saramma, P P; Sarma, P S; Thomas, Sanjeev V

2014-06-01

Women with epilepsy (WWE) have poorer knowledge and skill in child rearing than women without epilepsy. To evaluate the effect of a self-instructional module (SIM) on the child rearing knowledge (CRK) and practice (CRP) of WWE and developmental outcome of their babies. One hundred women in first trimester of pregnancy that were enrolled in to the Kerala Registry of Epilepsy and Pregnancy and consenting to participate were given a self instructional module (SIM) or a comparator booklet by random concealed allocation. Their child rearing knowledge (CRK) was assessed by a standardized protocol at entry (first trimester) and at 3-4 months postpartum. Their child rearing practice (CRP) was evaluated in third postpartum month. The developmental outcome of babies was assessed at 1 year of age as per registry protocol. Eighty eight women completed this 1 year study. The CRK score was significantly higher (p=.034) for the intervention group (32.91±5) when compared to the comparator group (30.61±5) However, a corresponding improvement in CRP score was not observed for the former. Developmental outcome of 68 babies showed a positive weak correlation between CRP and developmental quotient both mental and motor. The intervention group demonstrated significant increase in their CRK. Nevertheless the results did not indicate a significant improvement in the CRP. The SIM improved the CRK of WWE. Nevertheless, the child rearing practices did not show corresponding improvement. Copyright © 2014 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

Carnitine for fatigue in multiple sclerosis.

PubMed

Tejani, Aaron M; Wasdell, Michael; Spiwak, Rae; Rowell, Greg; Nathwani, Shabita

2012-05-16

Fatigue is reported to occur in up to 92% of patients with multiple sclerosis (MS) and has been described as the most debilitating of all MS symptoms by 28% to 40% of MS patients. To assess whether carnitine (enteral or intravenous) supplementation can improve the quality of life and reduce the symptoms of fatigue in patients with MS-related fatigue and to identify any adverse effects of carnitine when used for this purpose. A literature search was performed using Cochrane MS Group Trials Register (09 September 2011), Cochrane Central Register of Controlled Trials (CENTRAL) "The Cochrane Library 2011, issue 3", MEDLINE (PubMed) (1966-09 September 2011), EMBASE (1974-09 September 2011), and www.clinicaltrials.gov for ongoing trials retrieval. Reference lists of review articles and primary studies were also screened. A hand search of the abstract book of recent relevant conference symposia was also conducted. Personal contact with MS experts and a manufacturer (Source Naturals, United States) of carnitine formulation was contacted to determine if they knew of other clinical trials. No language restrictions were applied. Full reports of published and unpublished randomized controlled trials and quasi-randomized trials of any carnitine intervention in adults affected by multiple sclerosis with a clinical diagnosis of fatigue associated with multiple sclerosis were included. Data from the eligible trials was extracted and coded using a standardized data extraction form and entered into RevMan 5. Discrepancies were to be resolved by discussion with a third reviewer, however this was not necessary.The quality items to be assessed were method of randomization, allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention-to-treat analysis and completeness of follow up. The search identified one ongoing randomized, placebo-controlled, cross-over trial (expected completion 2013) and one completed randomized, active-comparator, cross-over trial. In the completed study, adult patients with relapsing-remitting and secondary progressive MS were exposed to both acetyl L-carnitine 2 grams daily and amantadine 200 mg daily The effects of carnitine on fatigue are unclear. There was no difference between carnitine and amantadine for the number of patients withdrawing from the study due to an adverse event (relative risk ratio 0.20; 95% confidence interval 0.03 to 1.55) and no patients experienced a serious adverse event in either treatment group. Mortality and quality of life were not reported. There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators. Results of the ongoing trial are eagerly anticipated in order to provide clarity.

Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.

PubMed

Fransen, Marlene; Nairn, Lillias; Winstanley, Julie; Lam, Paul; Edmonds, John

2007-04-15

To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits. A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb). At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.

Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomized controlled trial

PubMed Central

2013-01-01

Background Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation. Methods This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge. Results We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08). Conclusions Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 Please see related commentary: http://www.biomedcentral.com/10.1186/1741-7015-11-199. PMID:24228854

[Management of moderate to severe pediatric concealed penis in children by Devine's technique via incision between the penis and scrotum].

PubMed

Zhang, Xin-Sheng; Liu, Shi-Xiong; Xiang, Xue-Yan; Zhang, Wen-Gang; Tang, Da-Xing

2014-04-01

To search for a simple and effective surgical approach to the management of moderate to severe pediatric concealed penis in children. We used Devine's technique via incision between the penis and scrotum in the treatment of 68 cases of moderate to severe pediatric concealed penis. The patients were aged 3 -13 (mean 6.5) years, 30 with moderate and 38 with severe pediatric concealed penis. This strategy achieved good near- and long-term effects and satisfactory appearance of the penis, which was similar to that of circumcision. At 3 months after surgery, the penile length was 3 - 5.2 cm, averaging (2.35 +/- 0.35) cm. Devine's technique via incision between the penis and scrotum is a simple and effective surgical option for moderate to severe pediatric concealed penis in children.

Concealable Stigmatized Identities and Psychological Well-Being

PubMed Central

Quinn, Diane M.; Earnshaw, Valerie A.

2013-01-01

Many people have concealable stigmatized identities: Identities that can be hidden from others and that are socially devalued and negatively stereotyped. Understanding how these concealable stigmatized identities affect psychological well-being is critical. We present our model of the components of concealable stigmatized identities including valenced content – internalized stigma, experienced discrimination, anticipated stigma, disclosure reactions, and counter-stereotypic/positive information – and magnitude – centrality and salience. Research has shown that negatively valenced content is related to increased psychological distress. However, smaller identity magnitude may buffer this distress. We review the research available and discuss important areas for future work. PMID:23730326

Electronic symptom reporting between patient and provider for improved health care service quality: a systematic review of randomized controlled trials. part 2: methodological quality and effects.

PubMed

Johansen, Monika Alise; Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

2012-10-03

We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors' hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system. Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.

Electronic Symptom Reporting Between Patient and Provider for Improved Health Care Service Quality: A Systematic Review of Randomized Controlled Trials. Part 2: Methodological Quality and Effects

PubMed Central

Berntsen, Gro K Rosvold; Schuster, Tibor; Henriksen, Eva; Horsch, Alexander

2012-01-01

Background We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. Objective To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. Methods We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. Results Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors’ hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system. Conclusion Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results. PMID:23032363

Reactive Power Pricing Model Considering the Randomness of Wind Power Output

NASA Astrophysics Data System (ADS)

Dai, Zhong; Wu, Zhou

2018-01-01

With the increase of wind power capacity integrated into grid, the influence of the randomness of wind power output on the reactive power distribution of grid is gradually highlighted. Meanwhile, the power market reform puts forward higher requirements for reasonable pricing of reactive power service. Based on it, the article combined the optimal power flow model considering wind power randomness with integrated cost allocation method to price reactive power. Meanwhile, considering the advantages and disadvantages of the present cost allocation method and marginal cost pricing, an integrated cost allocation method based on optimal power flow tracing is proposed. The model realized the optimal power flow distribution of reactive power with the minimal integrated cost and wind power integration, under the premise of guaranteeing the balance of reactive power pricing. Finally, through the analysis of multi-scenario calculation examples and the stochastic simulation of wind power outputs, the article compared the results of the model pricing and the marginal cost pricing, which proved that the model is accurate and effective.

Keeping up appearances: the role of identity concealment in the workplace among adults with degenerative eye conditions and its relationship with wellbeing and career outcomes.

PubMed

Spiegel, Tali; De Bel, Vera; Steverink, Nardi

2016-01-01

This study aims to describe the interplay between the work trajectories and the passing patterns of individuals with degenerative eye conditions in different phases of their career, as well as the disease progression and the career and well-being outcomes associated with different works and passing trajectories. Qualitative interviews on the topic of work trajectories were conducted with 36 working or retired individuals with degenerative eye conditions. The "bigger picture" method was used to explore passing and concealment behavioral patterns, and their associations with various work trajectories. Five patterns of passing and concealment behavior in the workplace were identified and were linked with various work trajectories among visually impaired study participants: (1) no career adjustments, concealed condition throughout career; (2) revealed condition after adjusting career plans; (3) increasingly open about their condition over the course of their career; (4) engaged in career planning, always open about their condition; and (5) engaged in limited career planning, always open about their condition. Patterns characterized by less planning and more identity concealment were associated with more stress and lower levels of self-acceptance, while patterns characterized by more planning for vision deterioration and less passing behavior were associated with higher levels self-acceptance and fewer obstacles over the course of an individual's career. The study's findings can serve as a guide for health professionals. Many individuals with degenerative eye conditions try to conceal their identity as visually impaired in the professional setting. Different aspects of career outcomes (e.g. age of retirement) and wellbeing outcomes (e.g. self-acceptance and stress) associate with identity concealment patterns of individuals throughout their careers. Identifying concealment patterns will allow health professionals to tackle particular adverse outcomes and challenges associated with these patterns.

The Invisible Work of Closeting: A Qualitative Study About Strategies Used by Lesbian and Gay Persons to Conceal Their Sexual Orientation.

PubMed

Malterud, Kirsti; Bjorkman, Mari

2016-10-01

The last decades have offered substantial improvement regarding human rights for lesbian and gay (LG) persons. Yet LG persons are often in the closet, concealing their sexual orientation. We present a qualitative study based on 182 histories submitted from 161 LG individuals to a Web site. The aim was to explore experiences of closeting among LG persons in Norway. A broad range of strategies was used for closeting, even among individuals who generally considered themselves to be out of the closet. Concealment was enacted by blunt denial, clever avoidance, or subtle vagueness. Other strategies included changing or eliminating the pronoun or name of the partner in ongoing conversations. Context-dependent concealment, differentiating between persons, situations, or arenas, was repeatedly applied for security or convenience. We propose a shift from "being in the closet" to "situated concealment of sexual orientation."

Dynamic Resource Allocation and Access Class Barring Scheme for Delay-Sensitive Devices in Machine to Machine (M2M) Communications.

PubMed

Li, Ning; Cao, Chao; Wang, Cong

2017-06-15

Supporting simultaneous access of machine-type devices is a critical challenge in machine-to-machine (M2M) communications. In this paper, we propose an optimal scheme to dynamically adjust the Access Class Barring (ACB) factor and the number of random access channel (RACH) resources for clustered machine-to-machine (M2M) communications, in which Delay-Sensitive (DS) devices coexist with Delay-Tolerant (DT) ones. In M2M communications, since delay-sensitive devices share random access resources with delay-tolerant devices, reducing the resources consumed by delay-sensitive devices means that there will be more resources available to delay-tolerant ones. Our goal is to optimize the random access scheme, which can not only satisfy the requirements of delay-sensitive devices, but also take the communication quality of delay-tolerant ones into consideration. We discuss this problem from the perspective of delay-sensitive services by adjusting the resource allocation and ACB scheme for these devices dynamically. Simulation results show that our proposed scheme realizes good performance in satisfying the delay-sensitive services as well as increasing the utilization rate of the random access resources allocated to them.

Patients' ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial.

PubMed

Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

2015-07-01

Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful - RR 1.00 (95% CI 0.68-1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. © 2015 The Authors Allergy Published by John Wiley & Sons Ltd.

Concealed identification symbols and nondestructive determination of the identification symbols

DOEpatents

Nance, Thomas A.; Gibbs, Kenneth M.

2014-09-16

The concealing of one or more identification symbols into a target object and the subsequent determination or reading of such symbols through non-destructive testing is described. The symbols can be concealed in a manner so that they are not visible to the human eye and/or cannot be readily revealed to the human eye without damage or destruction of the target object. The identification symbols can be determined after concealment by e.g., the compilation of multiple X-ray images. As such, the present invention can also provide e.g., a deterrent to theft and the recovery of lost or stolen objects.

Fusion of radar and ultrasound sensors for concealed weapons detection

NASA Astrophysics Data System (ADS)

Felber, Franklin S.; Davis, Herbert T., III; Mallon, Charles E.; Wild, Norbert C.

1996-06-01

An integrated radar and ultrasound sensor, capable of remotely detecting and imaging concealed weapons, is being developed. A modified frequency-agile, mine-detection radar is intended to specify with high probability of detection at ranges of 1 to 10 m which individuals in a moving crowd may be concealing metallic or nonmetallic weapons. Within about 1 to 5 m, the active ultrasound sensor is intended to enable a user to identify a concealed weapon on a moving person with low false-detection rate, achieved through a real-time centimeter-resolution image of the weapon. The goal for sensor fusion is to have the radar acquire concealed weapons at long ranges and seamlessly hand over tracking data to the ultrasound sensor for high-resolution imaging on a video monitor. We have demonstrated centimeter-resolution ultrasound images of metallic and non-metallic weapons concealed on a human at ranges over 1 m. Processing of the ultrasound images includes filters for noise, frequency, brightness, and contrast. A frequency-agile radar has been developed by JAYCOR under the U.S. Army Advanced Mine Detection Radar Program. The signature of an armed person, detected by this radar, differs appreciably from that of the same person unarmed.

The association between concealing emotions at work and medical utilization in Korea.

PubMed

Seok, Hongdeok; Yoon, Jin-Ha; Lee, Wanhyung; Lee, June-Hee; Jung, Pil Kyun; Kim, Inah; Won, Jong-Uk; Roh, Jaehoon

2014-01-01

We aimed to investigate the association between concealing emotions at work and medical utilization. Data from the 2007-2009 4th Korea National Health and Nutrition Examination Survey (KNHANES IV) was used, 7,094 participants (3,837 males, 3,257 females) aged between 20 and 54 who were economically active and completed all necessary questionnaire items were included. Odds ratios (ORs) and 95% confidence intervals (95% CI) for differences in hospitalization, outpatient visits, and pharmaceutical drug use between those who concealed their emotions and those who did not were investigated using logistic regression models with and without gender stratification. Among those who concealed their emotions (n = 2,763), 47.4% were females, and 50.1% had chronic disease. In addition, 9.7% of the concealing emotions group had been hospitalized within the last year, 24.8% had been outpatients in the last two weeks, and 28.3% had used pharmaceutical drugs in the last two weeks. All ORs represent the odds of belonging to the concealing emotions group over the non-concealing emotions group. After adjustment for individual, occupational, socioeconomic and disease factors, the adjusted ORs (95% CI) in hospitalization are 1.29 (1.08 ~ 1.53) in the total population, 1.25 (0.98 ~ 1.60) in males and 1.30 (1.02 ~ 1.66) in females, in outpatient visits are 1.15 (1.02 ~ 1.29) in the total population, 1.05 (0.88 ~ 1.24) in males and 1.25 (1.06 ~ 1.47) in females and in pharmaceutical drug use are 1.12 (1.01 ~ 1.25) in the total population, 1.08 (0.92 ~ 1.27) in males and 1.14 (0.98 ~ 1.33) in females. Those who concealed their emotions at work were more likely to use medical services. Moreover, the health effects of concealing emotions at work might be more detrimental in women than in men.

Perioperative Aspirin for Prevention of Venous Thromboembolism: The PeriOperative ISchemia Evaluation-2 Trial and a Pooled Analysis of the Randomized Trials.

PubMed

Eikelboom, John W; Kearon, Clive; Guyatt, Gordon; Sessler, Daniel I; Yusuf, Salim; Cook, Deborah; Douketis, James; Patel, Ameen; Kurz, Andrea; Allard, Rene; Jones, Philip M; Dennis, Rodolfo J; Painter, Thomas W; Bergese, Sergio D; Leslie, Kate; Wijeysundera, Duminda N; Balasubramanian, Kumar; Duceppe, Emmanuelle; Miller, Scott; Diedericks, Johan; Devereaux, P J

2016-12-01

The PeriOperative ISchemia Evaluation-2 (POISE-2) trial compared aspirin with placebo after noncardiac surgery. The authors randomly assigned 10,010 patients undergoing noncardiac surgery to receive 200 mg aspirin or placebo 2 to 4 h before surgery and then 100 mg aspirin daily or placebo daily for up to 30 days after surgery. Herein, the authors report the effect of aspirin on venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, as well as an updated pooled analysis of randomized trials of antiplatelet therapy for VTE prevention in noncardiac surgery patients. Six thousand five hundred forty-eight patients (65.4%) received anticoagulant prophylaxis. VTE occurred in 53 patients (1.1%) allocated to aspirin and in 60 patients (1.2%) allocated to placebo (hazard ratio, 0.89; 95% CI, 0.61 to 1.28). Major or life-threatening bleeding occurred in 312 patients (6.3%) allocated to aspirin and in 256 patients (5.1%) allocated to placebo (hazard ratio, 1.22; 95% CI, 1.04 to 1.44). Concomitant use of anticoagulant prophylaxis did not modify the effect of aspirin on VTE or bleeding. Pooled analysis of the POISE-2 and Pulmonary Embolism Prevention trials demonstrated that symptomatic VTE occurred in 173 (1.3%) of 13,724 patients allocated to aspirin and in 246 (1.8%) of 13,730 patients allocated to placebo (odds ratio, 0.71; 95% CI, 0.56 to 0.89; heterogeneity P = 0.27; I = 17%); the impact of aspirin was very similar in those who did and did not receive pharmacologic prophylaxis. Pooled estimates for symptomatic VTE were similar to the pooled estimates for any deep vein thrombosis and pulmonary embolism from the POISE-2 trial, Pulmonary Embolism Prevention trial, and the Antiplatelet Trialists' Collaboration meta-analysis. Aspirin in the POISE-2 trial did not reduce VTE, but two thirds of patients received anticoagulant prophylaxis, there were few VTE events, and results were consistent with a wide range of aspirin effects. A pooled analysis of the randomized trials demonstrates evidence for the efficacy of aspirin for VTE prevention in hospitalized surgical patients.

Concealment of type 1 diabetes at work in Finland: a mixed-method study

PubMed Central

Munir, Fehmidah; Moilanen, Leena; Räsänen, Kimmo; Hänninen, Vilma

2018-01-01

Objectives To explore the possible reasons for concealing type 1 diabetes (T1D) at work. Methods The main set of data came from a cross-sectional survey (response rate 49.3%), the participants of which were 688 wage earners with T1D. Concealment of T1D was measured by asking respondents have they ever during their working career hidden their diabetes from their (A) colleagues and (B) line manager. Furthermore, semistructured interviews (n=20) were conducted to obtain deeper understanding. Questionnaire data were analysed using logistic regression analyses and qualitative interviews with inductive thematic analysis. Results About 30% of wage earners with T1D had concealed their condition during their working career from their colleagues and almost 20% from their line manager. Individuals aged 18–44 years age were more likely to conceal their T1D from their colleagues than older workers during their working career. Not disclosing T1D to the extended family (OR 5.24 (95% CI 2.06 to 13.35)), feeling an outsider at work (OR 2.47 (95% CI 1.58 to 3.84)), being embarrassed by receiving special attention at work (OR 1.99 (95% CI 1.33 to 2.96)) and neglecting treatment at work (OR 1.59 (95% CI 1.01 to 2.48)) were all associated with concealment of T1D from colleagues. The youngest age group of 18–24 years were more likely to conceal their T1D from their line managers than the older age groups during their working career. Not disclosing T1D to the extended family (OR 4.41 (95% CI 1.72 to 11.32)), feeling like an outsider at work (OR 2.51 (1.52 to 4.14)) and being embarrassed by receiving special attention at work (OR 1.81 (95% CI 1.13 to 2.91)) were associated with concealment of T1D from line managers. From the interviews, five main themes related to concealment emerged, expressing fears related to the consequences of telling: (1) being perceived as weak, (2) job discrimination, (3) unwanted attention, (4) being seen as a person who uses their T1D for seeking advantages and (5) losing privacy. Conclusions A considerable proportion of wage earners with T1D are concealing their diagnosis often because of feelings associated with stigma. Both overemphasis and underestimation of T1D at work by the colleagues or line manager may lead to concealing T1D and may thus be harmful to self-management of T1D. The obstacles in disclosing T1D might be diminished by giving adequate information at the workplace about the condition and its significance. PMID:29331976

A Concealed Barcode Identification System Using Terahertz Time-domain Spectroscopy

NASA Astrophysics Data System (ADS)

Guan, Yu; Yamamoto, Manabu; Kitazawa, Toshiyuki; Tripathi, Saroj R.; Takeya, Kei; Kawase, Kodo

2015-03-01

We present a concealed terahertz barcode/chipless tag to achieve remote identification through an obstructing material using terahertz radiation. We show scanned terahertz reflection spectral images of barcodes concealed by a thick obstacle. A concealed and double- side printed terahertz barcode structure is proposed, and we demonstrate that our design has better performance in definition than a single-side printed barcode using terahertz time-domain spectroscopy. This technique combines the benefits of a chipless tag to read encoded information covered by an optically opaque material with low cost and a simple fabrication process. Simulations are also described, along with an explanation of the principle of the terahertz barcode identification system.

Drug concealment in custody deaths--two cases.

PubMed

Busuttil, A

1994-06-01

Internal concealment of drugs of abuse is a well established method of transporting such substances to avoid detection while they are being smuggled across international frontier lines.(1,2) The same method has been used by dealers and 'pushers' in between purchases on their selling rounds to avoid detection by the police. These methods of hiding drugs may be used by persons taken into short-term custody, in their belief that potential withdrawal effects would thus be avoided by continued availability of their drugs. Two cases are reported in which such concealment was discovered at autopsy after death had occurred while in police custody. In one case the drug concealed was dihydrocodeine and was directly responsible for the death.

Out and healthy: Being more "out" about a concealable stigmatized identity may boost the health benefits of social support.

PubMed

Weisz, Bradley M; Quinn, Diane M; Williams, Michelle K

2016-12-01

This research examined whether the relationship between perceived social support and health would be moderated by level of outness for people living with different concealable stigmatized identities (mental illness, substance abuse, domestic violence, rape, or childhood abuse). A total of 394 people living with a concealable stigmatized identity completed a survey. Consistent with hypotheses, at high levels of outness, social support predicted better health; at low levels of outness, social support was less predictive of health. People concealing a stigmatized identity may only be able to reap the health benefits of social support if they are "out" about the stigmatized identity. © The Author(s) 2015.

Concealed wire tracing apparatus

DOEpatents

Kronberg, J.W.

1994-05-31

An apparatus and method that combines a signal generator and a passive signal receiver to detect and record the path of partially or completely concealed electrical wiring without disturbing the concealing surface is disclosed. The signal generator applies a series of electrical pulses to the selected wiring of interest. The applied pulses create a magnetic field about the wiring that can be detected by a coil contained within the signal receiver. An audible output connected to the receiver and driven by the coil reflects the receivers position with respect to the wiring. The receivers audible signal is strongest when the receiver is directly above the wiring and the long axis of the receivers coil is parallel to the wiring. A marking means is mounted on the receiver to mark the location of the wiring as the receiver is directed over the wiring's concealing surface. Numerous marks made on various locations of the concealing surface will trace the path of the wiring of interest. 4 figs.

Associations Between Secret-Keeping and Quality of Life in Older Adults.

PubMed

Maas, Joyce; Wismeijer, Andreas A J; Van Assen, Marcel A L M

2018-01-01

This study examined the effects of secrecy on quality of life in a sample consisting of older adults (>50 years; N = 301). Three key components of secrecy were examined with the Tilburg Secrecy Scale-25 (TSS25; possession of a secret, self-concealment, and cognitive preoccupation). The TSS25 distinguishes between the tendency to conceal personal information (self-concealment) and the tendency to worry or ruminate about the secret (cognitive preoccupation), thereby enabling investigation of the effects of secrecy on quality of life in detail. Confirming previous findings in younger samples, we found a positive effect of possession of a secret on quality of life, after controlling for both TSS25's self-concealment and cognitive preoccupation. This suggests that keeping secrets may have a positive association with quality of life in older adults as well, as long as they do not have the tendency to self-conceal and are not cognitively preoccupied with their secret.

Geochemical Data for Samples Collected in 2008 Near the Concealed Pebble Porphyry Cu-Au-Mo Deposit, Southwest Alaska

USGS Publications Warehouse

Fey, David L.; Granitto, Matthew; Giles, Stuart A.; Smith, Steven M.; Eppinger, Robert G.; Kelley, Karen D.

2009-01-01

In the summer of 2007, the U.S. Geological Survey (USGS) began an exploration geochemical research study over the Pebble porphyry copper-gold-molybdenum deposit. This report presents the analytical data collected in 2008. The Pebble deposit is world class in size, and is almost entirely concealed by tundra, glacial deposits, and post-Cretaceous volcanic rocks. The Pebble deposit was chosen for this study because it is concealed by surficial cover rocks, is relatively undisturbed (except for exploration company drill holes), is a large mineral system, and is fairly well-constrained at depth by the drill hole geology and geochemistry. The goals of this study are to 1) determine whether the concealed deposit can be detected with surface samples, 2) better understand the processes of metal migration from the deposit to the surface, and 3) test and develop methods for assessing mineral resources in similar concealed terrains. The analytical data are presented as an integrated Microsoft Access 2003 database and as separate Excel files.

Detection of a concealed object

DOEpatents

Keller, Paul E [Richland, WA; Hall, Thomas E [Kennewick, WA; McMakin, Douglas L [Richland, WA

2010-11-16

Disclosed are systems, methods, devices, and apparatus to determine if a clothed individual is carrying a suspicious, concealed object. This determination includes establishing data corresponding to an image of the individual through interrogation with electromagnetic radiation in the 200 MHz to 1 THz range. In one form, image data corresponding to intensity of reflected radiation and differential depth of the reflecting surface is received and processed to detect the suspicious, concealed object.

Detection of a concealed object

DOEpatents

Keller, Paul E [Richland, WA; Hall, Thomas E [Kennewick, WA; McMakin, Douglas L [Richland, WA

2008-04-29

Disclosed are systems, methods, devices, and apparatus to determine if a clothed individual is carrying a suspicious, concealed object. This determination includes establishing data corresponding to an image of the individual through interrogation with electromagnetic radiation in the 200 MHz to 1 THz range. In one form, image data corresponding to intensity of reflected radiation and differential depth of the reflecting surface is received and processed to detect the suspicious, concealed object.

The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

PubMed

Young, Sean D; Cumberland, William G; Nianogo, Roch; Menacho, Luis A; Galea, Jerome T; Coates, Thomas

2015-01-01

Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2·61, 95% CI 1·55–4·38). No adverse events were reported. Development of peer-mentored social media communities seemed to be an efficacious method to increase HIV testing among high-risk populations in Peru. Results suggest that the HOPE social media intervention could improve HIV testing rates among MSM in Peru. National Institute of Mental Health.

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine.

PubMed

Wang, Ling; Li, Yulin; Li, Jing; Zhang, Mingming; Xu, Lin; Yuan, Wenming; Wang, Gang; Hopewell, Sally

2010-07-08

Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item. The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality.

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

PubMed Central

2010-01-01

Background Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Method Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). Results We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item. Conclusion The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality. PMID:20615225

Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? A protocol for a meta-epidemiological study of PDE-5 inhibitors

PubMed Central

2012-01-01

Background Patients’ expectations of treatment effects may contribute to positive (placebo) and negative (nocebo) outcomes. The effect of patient expectations may be pronounced in subjectively assessed conditions, such as male erectile dysfunction. The aim of this project is to examine the magnitude of expectancy in trials of phosphodiesterase-5 inhibitors. We hypothesize that randomized controlled trials with inadequate blinding will report enhanced placebo effects for intervention groups and nocebo effects for placebo groups, compared with adequately blinded studies. Methods/design We will quantify the magnitude of expectancy by comparing the effect estimates of trials with inadequate and adequate blinding. Blinding will be assessed using four domains from the Cochrane ‘risk-of-bias’ tool: allocation concealment; blinding of patient; caregiver; and outcome assessor. Our secondary aim is to identify factors that can modify expectations, such as prior experience with the intervention and drug side effects. We will perform an electronic search using a combination of controlled vocabulary and free text words in the following databases: MEDLINE, EMBASE, CENTRAL, and a clinical trials register. We will include randomized controlled trials, with either parallel or crossover design, that compare one phosphodiesterase-5 inhibitor with a placebo. The study’s primary aim should be to investigate the efficacy of phosphodiesterase-5 inhibitors for treating male erectile dysfunction. Screening will take place at two levels: abstracts and titles, followed by full text reports. Two reviewers will independently extract data on the primary outcome and assess risk of bias. We will meta-analyze treatment effects, if appropriate, to assess the magnitude of enhanced placebo effects and nocebo effects in intervention and placebo groups, respectively. We will explore possible mediators of placebo and nocebo effects with subgroup and meta-regression analyses. Discussion Treatments may confer significant costs and risk of adverse effects; it is important, therefore, to determine whether the effects of treatments are larger than expectancy alone. If treatment expectations can be used in a non-deceptive way to produce clinically advantageous outcomes, then it may be possible to incorporate such mechanisms into evidence-based healthcare decision-making. PMID:23151403

Randomized controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with intrauterine infection: study protocol

PubMed Central

2010-01-01

Background Spontaneous preterm deliveries that occur before the 34th week of gestation, and particularly before the 32nd week of gestation, have been strongly associated to intrauterine infection, ascending from vagina, and represent the largest portion of neonatal deaths and neurological problems. Bacterial vaginosis, characterized by a diminished or absent flora of lactobacilli and increased colonization of several anaerobic or facultative microorganisms, increases two times the risk of preterm delivery before the 34th week. Trials of antibiotics failed to show efficacy and effectiveness against spontaneous preterm birth related to bacterial vaginosis. Some studies indicate benefit from selected probiotics to treat genitourinary infections, including bacterial vaginosis. Objective The purpose of this study is to evaluate the effectiveness of the early administration of selected probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate degree infection to reduce the occurrence of spontaneous preterm delivery and related neonatal mortality and morbidity. Methods/Design Women attending public prenatal care services in Rio de Janeiro will be screened to select asymptomatic pregnant women, less than 20 weeks' gestation, with no indication of elective preterm delivery. Those with vaginal pH > = 4.5 and a Nugent score between 4 and 10 (intermediate degree infection or bacterial vaginosis) will be randomized to either the placebo or the intervention group, after written informed consent. Intervention consists in the use of probiotics, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14, 2 capsules a day, each capsule containing more than one million bacilli of each strain, for 6-12 weeks, up to the 24th-25th wk of gestation. Ancillary analyses include quantification of selected cervicovaginal cytokines and genotyping of selected polymorphisms. The randomization process is stratified for history of preterm delivery and blocked. Allocation concealment was designed as well as blinding of women, caregivers and outcome evaluators. The study will be supervised by an independent monitoring committee. Outcomes under study are preterm delivery (< 34- < 32 weeks of gestation) and associated neonatal complications: early neonatal sepsis, bronchopulmonary dysplasia, periventricular leukomalacia, necrotizing enterocolitis, and prematurity-related retinopathy; definitions were adapted from those recommended by the 2002 version of the Vermont-Oxford Network. Trial registration at NIH register: NCT00303082. PMID:20591191

Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial.

PubMed

Luvizutto, Gustavo José; Rizzati, Gabriela Rizzo Soares; Fogaroli, Marcelo Ortolani; Rodrigues, Rodrigo Thomazi; Ribeiro, Priscila Watson; de Carvalho Nunes, Hélio Rubens; Braga, Gabriel Pereira; da Costa, Rafael Dalle Molle; Bazan, Silméia Garcia Zanati; de Lima Resende, Luiz Antônio; Conforto, Adriana Bastos; Bazan, Rodrigo

2016-10-03

Unilateral spatial neglect (USN) is characterized by the inability to report or respond to people or objects that are presented in the spatial hemisphere that is contralateral to the lesioned hemisphere of the brain. USN has been associated with poor functional outcomes and long stays in hospitals and rehabilitation centers. Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), has been used in people who have been affected by USN after stroke. The effects of such treatment could provide new insights for health professionals and policy-makers. The aim of this study will be to evaluate the effectiveness and safety of tDCS for USN after stroke. A prospective randomized controlled trial with two parallel groups will be conducted, which will aim to recruit 60 patients with USN after ischemic or hemorrhagic stroke. Participants will be randomly placed into the following four treatment groups: (1) anodal tDCS over the right parietal lobe (n = 15), (2) cathodal tDCS over the left parietal lobe (n = 15), (3) a sham group of anodal tDCS over the right parietal lobe (n = 15), and (4) a sham group of cathodal tDCS over the left parietal lobe (n = 15). Blinded assessors will conduct two baseline assessments and one post-intervention assessment. The primary outcome measure will be the level of USN as assessed by the conventional Behavioral Inattention Tasks and the Catherine Bergego Scale. Secondary measures will include neurological capacity (based on the Scandinavian Stroke Scale), functional capacity (based on the Functional Independence Measure and Modified Rankin Scale), autonomy (based on the Barthel Index), and quality of life (based on the EuroQol-5D). Group allocation will be concealed, and all analyses will be based on an intention-to-treat principle. This study will explore the effects of more than 15 sessions of tDCS on the level of USN, functional capacity, autonomy, and quality of life in patients with USN after stroke. This proposed study has the potential to identify a new, evidence-based intervention that can enhance perception and independent living in patients with USN after stroke. REBEC - RBR-78jvzx , registered on 13 March 2016.

Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness.

PubMed

Zhao, Wenle; Weng, Yanqiu; Wu, Qi; Palesch, Yuko

2012-01-01

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design. Copyright © 2011 John Wiley & Sons, Ltd.

Why does primary angioplasty not work in registries? Quantifying the susceptibility of real-world comparative effectiveness data to allocation bias.

PubMed

Sen, Sayan; Davies, Justin E; Malik, Iqbal S; Foale, Rodney A; Mikhail, Ghada W; Hadjiloizou, Nearchos; Hughes, Alun; Mayet, Jamil; Francis, Darrel P

2012-11-01

Meta-analysis of registries (comparative effectiveness research) shows that primary angioplasty and fibrinolysis have equivalent real-world survival. Yet, randomized, controlled trials consistently find primary angioplasty superior. Can unequal allocation of higher-risk patients in registries have masked primary angioplasty benefit? First, we constructed a model to demonstrate the potential effect of allocation bias. We then analyzed published registries (55022 patients) for allocation of higher-risk patients (Killip class ≥1) to determine whether the choice of reperfusion therapy was affected by the risk level of the patient. Meta-regression was used to examine the relationship between differences in allocation of high-risk patient to primary angioplasty or fibrinolysis and mortality. Initial modeling suggested that registry outcomes are sensitive to allocation bias of high-risk patients. Across the registries, the therapy receiving excess high-risk patients had worse mortality. Unequal distribution of high-risk status accounted for most of the between-registry variance (adjusted R(2)(meta)=83.1%). Accounting for differential allocation of higher-risk patients, primary angioplasty gave 22% lower mortality (odds ratio, 0.78; 95% confidence interval, 0.64-0.97; P=0.029). We derive a formula, called the number needed to abolish, highlighting situations in which comparative effectiveness studies are particularly vulnerable to this bias. In ST-segment elevation myocardial infarction, clinicians' preference for management of a few high-risk patients can shift mortality substantially. Comparative effectiveness research in any disease is vulnerable to this, especially diseases with an immediately identifiable high-risk subgroup that clinicians prefer to allocate to 1 therapy. For this reason, preliminary indications from registry-based comparative effectiveness research should be definitively tested by randomized, controlled trials.

Social recovery therapy in combination with early intervention services for enhancement of social recovery in patients with first-episode psychosis (SUPEREDEN3): a single-blind, randomised controlled trial.

PubMed

Fowler, David; Hodgekins, Jo; French, Paul; Marshall, Max; Freemantle, Nick; McCrone, Paul; Everard, Linda; Lavis, Anna; Jones, Peter B; Amos, Tim; Singh, Swaran; Sharma, Vimal; Birchwood, Max

2018-01-01

Provision of early intervention services has increased the rate of social recovery in patients with first-episode psychosis; however, many individuals have continuing severe and persistent problems with social functioning. We aimed to assess the efficacy of early intervention services augmented with social recovery therapy in patients with first-episode psychosis. The primary hypothesis was that social recovery therapy plus early intervention services would lead to improvements in social recovery. We did this single-blind, phase 2, randomised controlled trial (SUPEREDEN3) at four specialist early intervention services in the UK. We included participants who were aged 16-35 years, had non-affective psychosis, had been clients of early intervention services for 12-30 months, and had persistent and severe social disability, defined as engagement in less than 30 h per week of structured activity. Participants were randomly assigned (1:1), via computer-generated randomisation with permuted blocks (sizes of four to six), to receive social recovery therapy plus early intervention services or early intervention services alone. Randomisation was stratified by sex and recruitment centre (Norfolk, Birmingham, Lancashire, and Sussex). By necessity, participants were not masked to group allocation, but allocation was concealed from outcome assessors. The primary outcome was time spent in structured activity at 9 months, as measured by the Time Use Survey. Analysis was by intention to treat. This trial is registered with ISRCTN, number ISRCTN61621571. Between Oct 1, 2012, and June 20, 2014, we randomly assigned 155 participants to receive social recovery therapy plus early intervention services (n=76) or early intervention services alone (n=79); the intention-to-treat population comprised 154 patients. At 9 months, 143 (93%) participants had data for the primary outcome. Social recovery therapy plus early intervention services was associated with an increase in structured activity of 8·1 h (95% CI 2·5-13·6; p=0·0050) compared with early intervention services alone. No adverse events were deemed attributable to study therapy. Our findings show a clinically important benefit of enhanced social recovery on structured activity in patients with first-episode psychosis who received social recovery therapy plus early intervention services. Social recovery therapy might be useful in improving functional outcomes in people with first-episode psychosis, particularly in individuals not motivated to engage in existing psychosocial interventions targeting functioning, or who have comorbid difficulties preventing them from doing so. National Institute for Health Research. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Antithrombotic drug therapy for IgA nephropathy: a meta analysis of randomized controlled trials.

PubMed

Liu, Xiu-Juan; Geng, Yan-Qiu; Xin, Shao-Nan; Huang, Guo-Ming; Tu, Xiao-Wen; Ding, Zhong-Ru; Chen, Xiang-Mei

2011-01-01

Antithrombotic agents, including antiplatelet agents, anticoagulants and thrombolysis agents, have been widely used in the management of immunoglobulin A (IgA) nephropathy in Chinese and Japanese populations. To systematically evaluate the effects of antithrombotic agents for IgA nephropathy. Data sources consisted of MEDLINE, EMBASE, the Cochrane Library, Chinese Biomedical Literature Database (CBM), Chinese Science and Technology Periodicals Databases (CNKI) and Japana Centra Revuo Medicina (http://www.jamas.gr.jp) up to April 5, 2011. The quality of the studies was evaluated from the intention to treat analysis and allocation concealment, as well as by the Jadad method. Meta-analyses were performed on the outcomes of proteinuria and renal function. Six articles met the predetermined inclusion criteria. Antithrombotic agents showed statistically significant effects on proteinuria (p<0.0001) but not on the protection of renal function (p=0.07). The pooled risk ratio for proteinuria was 0.53, [95% confidence intervals (CI): 0.41-0.68; I(2)=0%] and for renal function it was 0.42 (95% CI 0.17-1.06; I(2)=72%). Subgroup analysis showed that dipyridamole was beneficial for proteinuria (p=0.0003) but had no significant effects on protecting renal function. Urokinase had statistically significant effects both on the reduction of proteinuria (p=0.0005) and protecting renal function (p<0.00001) when compared with the control group. Antithrombotic agents had statistically significant effects on the reduction of proteinuria but not on the protection of renal function in patients with IgAN. Urokinase had statistically significant effects both on the reduction of proteinuria and on protecting renal function. Urokinase was shown to be a promising medication and should be investigated further.

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder.

PubMed

Gerger, H; Munder, T; Gemperli, A; Nüesch, E; Trelle, S; Jüni, P; Barth, J

2014-11-01

To summarize the available evidence on the effectiveness of psychological interventions for patients with post-traumatic stress disorder (PTSD). We searched bibliographic databases and reference lists of relevant systematic reviews and meta-analyses for randomized controlled trials that compared specific psychological interventions for adults with PTSD symptoms either head-to-head or against control interventions using non-specific intervention components, or against wait-list control. Two investigators independently extracted the data and assessed trial characteristics. The analyses included 4190 patients in 66 trials. An initial network meta-analysis showed large effect sizes (ESs) for all specific psychological interventions (ESs between -1.10 and -1.37) and moderate effects of psychological interventions that were used to control for non-specific intervention effects (ESs -0.58 and -0.62). ES differences between various types of specific psychological interventions were absent to small (ES differences between 0.00 and 0.27). Considerable between-trial heterogeneity occurred (τ²= 0.30). Stratified analyses revealed that trials that adhered to DSM-III/IV criteria for PTSD were associated with larger ESs. However, considerable heterogeneity remained. Heterogeneity was reduced in trials with adequate concealment of allocation and in large-sized trials. We found evidence for small-study bias. Our findings show that patients with a formal diagnosis of PTSD and those with subclinical PTSD symptoms benefit from different psychological interventions. We did not identify any intervention that was consistently superior to other specific psychological interventions. However, the robustness of evidence varies considerably between different psychological interventions for PTSD, with most robust evidence for cognitive behavioral and exposure therapies.

Exergames for women with fibromyalgia: a randomised controlled trial to evaluate the effects on mobility skills, balance and fear of falling.

PubMed

Collado-Mateo, Daniel; Dominguez-Muñoz, Francisco J; Adsuar, Jose C; Merellano-Navarro, Eugenio; Gusi, Narcis

2017-01-01

Exergames are a new form of rehabilitation that combine the characteristics of physical exercise and the benefits of non-immersive virtual reality (VR). Effects of this novel therapy in women fibromyalgia are still unknown. The objective was to evaluate the effects of exergame-based intervention on mobility skills, balance and fear of falling in women with fibromyalgia. This study was a randomized controlled trial with concealed allocation. Seventy-six women with fibromyalgia were divided into two groups: the exercise group received an eight week intervention based on exergames, while the control group continued their usual activities. Mobility skills were evaluated using the timed up and go test, while balance was assessed using the functional reach test, and the CTSIB protocol. Fear of falling was evaluated on a scale of 0-100 (0, no fear; 100, extreme fear). Measurements were performed before and after the intervention. A repeated-measures linear mixed model was used to compare the effects of the intervention between the two groups. The exercise group was significantly quicker than the control group in the timed up and go test (MD, -0.71; 95% CI [-1.09-0.32]; p  < 0.001). There were also significant improvements in functional reach and a reduced fear of falling (MD, 4.34; 95% CI [1.39-7.30]; p  = 0.005 and MD, -9.85; 95% CI [-0.19--0.08]; p  = 0.048, respectively). The improved TUG observed herein was better than the smallest real difference. Based on the results on mobility skills, balance and fear of falling, exergames may be an effective tool as a therapy for women with fibromyalgia.

The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial.

PubMed

Merenstein, D J; Smith, K H; Scriven, M; Roberts, R F; Sanders, M E; Petterson, S

2010-07-01

Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements. Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1-3 years attending daycare/school centers. Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Outpatient participants in the Washington, DC area. 182 healthy children between the age of 1 and 3 years attending daycare/school at least 3 days a week. Active was a strawberry yogurt-based drink supplemented with Bifidobacterium animalis ssp. lactis (B. lactis) BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12. Primary objective was to determine if consumption of a probiotic-containing yogurt-based drink decreases absences due to illnesses from daycare for children ages 1-3 years. Secondary was to determine if probiotic-containing yogurt-based drink improves overall parental satisfaction due to decreased absences from work and an overall healthier child. There were no significant differences in the days of missed school per group, with 51.9% in the active group and 47.1% in the placebo group missing at least 1 day of school throughout the study. Additionally, there were no differences in any secondary outcomes among the groups. Consumption of a yogurt-based drink delivering 10(10) CFU of Bifidobacterium animalis ssp. lactis (B. lactis) BB-12 per day did not decrease the number of days missed of school due to an illness. Additional independent research on the potential of BB-12 to reduce illness in children needs to be conducted.

Cervical kinematic training with and without interactive VR training for chronic neck pain - a randomized clinical trial.

PubMed

Sarig Bahat, Hilla; Takasaki, Hiroshi; Chen, Xiaoqi; Bet-Or, Yaheli; Treleaven, Julia

2015-02-01

Impairments in cervical kinematics are common in patients with neck pain. A virtual reality (VR) device has potential to be effective in the management of these impairments. The objective of this study was to investigate the effect of kinematic training (KT) with and without the use of an interactive VR device. In this assessor-blinded, allocation-concealed pilot clinical trial, 32 participants with chronic neck pain were randomised into the KT or kinematic plus VR training (KTVR) group. Both groups completed four to six training sessions comprising of similar KT activities such as active and quick head movements and fine head movement control and stability over five weeks. Only the KTVR group used the VR device. The primary outcome measures were neck disability index (NDI), cervical range of motion (ROM), head movement velocity and accuracy. Kinematic measures were collected using the VR system that was also used for training. Secondary measures included pain intensity, TAMPA scale of kinesiophobia, static and dynamic balance, global perceived effect and participant satisfaction. The results demonstrated significant (p < 0.05) improvements in NDI, ROM (rotation), velocity, and the step test in both groups post-intervention. At 3-month post-intervention, these improvements were mostly sustained; however there was no control group, which limits the interpretation of this. Between-group analysis showed a few specific differences including global perceived change that was greater in the KTVR group. This pilot study has provided directions and justification for future research exploring training using kinematic training and VR for those with neck pain in a larger cohort. Copyright © 2014 Elsevier Ltd. All rights reserved.

Transcranial direct current stimulation (tDCS) to improve naming ability in post-stroke aphasia: A critical review.

PubMed

ALHarbi, Mohammed F; Armijo-Olivo, Susan; Kim, Esther S

2017-08-14

Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation tool that can be used to influence cortical brain activity to induce measurable behavioral changes. Although there is growing evidence that tDCS combined with behavioural language therapy could boost language recovery in patients with post-stroke aphasia, there is great variability in patient characteristics, treatment protocols, and outcome measures in these studies that poses challenges for analyzing the evidence. The purpose of this study is to critically analyze the methodological rigor of the evidence regarding the use of tDCS for post-stroke anomia. This critical review was conducted by searching four databases (MEDLINE, EMBase, PsycINFO, and CINAHL). Nineteen studies fully met the inclusion criteria. Three critical appraisal tools and Robey and Schultz's (1998) five- phase model for conducting clinical outcome research were adopted to evaluate and analyze the current level of evidence. Methodological issues of the studies were also identified. The current level of evidence for using tDCS for anomia is at the pre-efficacy level with emerging evidence at the efficacy level. Lack of proper evaluation of carry-over effects in cross-over studies, lack of or unclear randomization, allocation concealment, and incomplete data handling were the main methodological issues that could threaten the validity of the tDCS for anomia studies. Several methodological issues have been identified in pre-efficacy studies that pose challenges in determining whether tDCS is a beneficial adjunct to behavioral aphasia therapy. Future studies need to improve the quality of the methods used to investigate the effect of tDCS for anomia. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of 4-aminopyridine on cardiac repolarization, PR interval, and heart rate in patients with spinal cord injury.

PubMed

Isoda, Wakana C; Segal, Jack L

2003-02-01

To determine the effects of 4-aminopyridine (4-AP) on heart rate and PR, QT, and QTc intervals in patients with longstanding spinal cord injury (SCI). Randomized, active-treatment-controlled, dose level-blinded study, with allocation concealed. University-affiliated, tertiary care medical center. Sixty otherwise healthy male and female outpatients with traumatic SCI of more than 1 year's duration. Intervention. Oral administration and dose titration to tolerance of an immediate-release formulation of 4-AP. The PR interval, heart rate, QT interval, and QTc interval obtained from standard 12-lead electrocardiograms (ECGs) at baseline (before administration of 4-AP) and after 1 month of treatment were compared. The QTc intervals were derived by using Bazett's formula (equation) incorporated into standard computerized analyses of 12-lead ECG printouts. The paired t test was performed to test for the significance of differences between means and variances. No statistically significant differences were noted in heart rate or between ECG time intervals measured at baseline and after 1 month of treatment with 4-AP among all patients with SCI or between subgroups stratified by injury level (tetraplegia, paraplegia) or sex. During the 1-month period that 4-AP was administered, the heart rate and PR, QT, and QTc intervals all remained unchanged and stayed well within normal range in comparison to literature-derived control values. 4-Aminopyridine does not appear to influence the length of cardiac time intervals or heart rate and, hence, is unlikely to cause potentially life-threatening ventricular dysrrhythmias when administered long-term and taken orally in dosages of up to 30 mg/day. Specifically, cardiac repolarization (QTc interval) is unaffected in patients with SCI who continuously receive 4-AP for up to 1 month.

US army land condition-trend analysis (LCTA) program

NASA Astrophysics Data System (ADS)

Diersing, Victor E.; Shaw, Robert B.; Tazik, David J.

1992-05-01

The US Army Land Condition-Trend Analysis (LCTA) program is a standardized method of data collection, analysis, and reporting designed to meet multiple goals and objectives. The method utilizes vascular plant inventories, permanent field plot data, and wildlife inventories. Vascular plant inventories are used for environmental documentation, training of personnel, species identification during LCTA implementation, and as a survey for state and federal endangered or threatened species. The permanent field plot data documents the vegetational, edaphic, topographic, and disturbance characteristics of the installation. Inventory plots are allocated in a stratified random fashion across the installation utilizing a geographic information system that integrates satellite imagery and soil survey information. Ground cover, canopy cover, woody plant density, slope length, slope gradient, soil information, and disturbance data are collected at each plot. Plot data are used to: (1) describe plant communities, (2) characterize wildlife and threatened and endangered species habitat, (3) document amount and kind of military and nonmilitary disturbance, (4) determine the impact of military training on vegetation and soil resources, (5) estimate soil erosion potential, (6) classify land as to the kind and amount of use it can support, (7) determine allowable use estimates for tracked vehicle training, (8) document concealment resources, (9) identify lands that require restoration and evaluate the effectiveness of restorative techniques, and (10) evaluate potential acquisition property. Wildlife inventories survey small and midsize mammals, birds, bats, amphibians, and reptiles. Data from these surveys can be used for environmental documentation, to identify state and federal endangered and threatened species, and to evaluate the impact of military activities on wildlife populations. Short- and long-term monitoring of permanent field plots is used to evaluate and adjust land management decisions.

Systematic review with meta-analysis: online psychological interventions for mental and physical health outcomes in gastrointestinal disorders including irritable bowel syndrome and inflammatory bowel disease.

PubMed

Hanlon, I; Hewitt, C; Bell, K; Phillips, A; Mikocka-Walus, A

2018-06-14

Online psychotherapy has been successfully used as supportive treatment in many chronic illnesses. However, there is a lack of evidence on its role in the management of gastrointestinal (GI) diseases. To examine whether online psychological interventions improve mental and physical outcomes in gastrointestinal diseases. We searched CINAHL Plus, MEDLINE, EMBASE, Health Management Information Consortium, PsycINFO, British Nursing Index, Cochrane Library, a specialised register of the IBD/FBD Cochrane Group, MEDLINE (PubMed) WHO International Clinical Trial Registry, ClinicalTrials.gov, and reference lists of all papers included in the review. The Cochrane Risk of Bias Tool was used to assess internal validity. Where possible, data were pooled using random-effects meta-analysis. We identified 11 publications (encompassing nine studies) meeting inclusion criteria. One study had a high risk of selection bias (allocation concealment), all studies had a high risk of performance and detection bias. Eight studies were included in the meta-analyses (6 on irritable bowel syndrome [IBS] and two on inflammatory bowel disease [IBD]). Online cognitive behavioural therapy (CBT) was shown to significantly improve gastrointestinal symptom-specific anxiety (MD: -8.51, 95% CI -12.99 to -4.04, P = 0.0002) and lessen symptom-induced disability (MD: -2.78, 95% CI -5.43 to -0.12, P = 0.04) in IBS post intervention. There was no significant effect of online CBT on any other outcomes in IBS. No significant effect of online psychotherapy was demonstrated in IBD. There is insufficient evidence to demonstrate the effectiveness of online CBT to manage mental and physical outcomes in gastrointestinal diseases. © 2018 John Wiley & Sons Ltd.

Nonpharmacologic Interventions for Improving Sleep Disturbances in Patients With Lung Cancer: A Systematic Review and Meta-analysis.

PubMed

Papadopoulos, Dimitrios; Papadoudis, Apostolos; Kiagia, Maria; Syrigos, Konstantinos

2018-05-01

Lung cancer patients experience higher levels of sleep disturbances compared to other cancer patients, and this leads to greater distress, poorer function, and lower quality of life. Nonpharmacologic interventions have demonstrated improvements in the context of breast cancer, but their efficacy in the lung cancer population is unclear. The aim of this review was to determine the effects of any nonpharmacologic intervention on sleep quality of lung cancer patients. Intervention studies of any design that reported primary or secondary outcomes on sleep quality were included. Databases searched were Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and PsycINFO. Risk of bias was assessed regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. Twenty-two studies were identified with a total of 1272 participants. Pittsburgh Sleep Quality Index was the most common instrument used. Statistically significant results were observed for all intervention categories examined in the short-term follow-up period: exercise and rehabilitation programs (standardized mean difference [SMD]: -0.43, 95% CI: -0.68, -0.19, P = 0.0005); information, psychoeducation, and symptom screening interventions (SMD: -0.87, 95% CI: -1.21, -0.54, P < 0.00001); and mind-body interventions (SMD: -0.88, 95% CI: -1.59, -0.16, P = 0.02). However, effectiveness was lower and nonsignificant when evaluated over one month after completion. Limitations include the high heterogeneity of interventions and outcome measures, in addition to small sample sizes and high risk of bias within studies. Because they do not allow for a clear interpretation of the results, it is recommended that every patient should be assessed individually to guide a possible referral. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial.

PubMed

Chang, Anne B; Grimwood, Keith; Wilson, Andrew C; van Asperen, Peter P; Byrnes, Catherine A; O'Grady, Kerry-Ann F; Sloots, Theo P; Robertson, Colin F; Torzillo, Paul J; McCallum, Gabrielle B; Masters, Ian B; Buntain, Helen M; Mackay, Ian M; Ungerer, Jacobus; Tuppin, Joanne; Morris, Peter S

2013-02-20

Bronchiectasis unrelated to cystic fibrosis (CF) is being increasingly recognized in children and adults globally, both in resource-poor and in affluent countries. However, high-quality evidence to inform management is scarce. Oral amoxycillin-clavulanate is often the first antibiotic chosen for non-severe respiratory exacerbations, because of the antibiotic-susceptibility patterns detected in the respiratory pathogens commonly associated with bronchiectasis. Azithromycin has a prolonged half-life, and with its unique anti-bacterial, immunomodulatory, and anti-inflammatory properties, presents an attractive alternative. Our proposed study will test the hypothesis that oral azithromycin is non-inferior (within a 20% margin) to amoxycillin-clavulanate at achieving resolution of non-severe respiratory exacerbations by day 21 of treatment in children with non-CF bronchiectasis. This will be a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial involving six Australian and New Zealand centers. In total, 170 eligible children will be stratified by site and bronchiectasis etiology, and randomized (allocation concealed) to receive: 1) azithromycin (5 mg/kg daily) with placebo amoxycillin-clavulanate or 2) amoxycillin-clavulanate (22.5 mg/kg twice daily) with placebo azithromycin for 21 days as treatment for non-severe respiratory exacerbations. Clinical data and a parent-proxy cough-specific quality of life (PC-QOL) score will be obtained at baseline, at the start and resolution of exacerbations, and on day 21. In most children, blood and deep-nasal swabs will also be collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 21. The main secondary outcome is the PC-QOL score. Other outcomes are: time to next exacerbation; requirement for hospitalization; duration of exacerbation, and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood inflammatory markers will be reported where available. Currently, there are no published randomized controlled trials (RCT) to underpin effective, evidence-based management of acute respiratory exacerbations in children with non-CF bronchiectasis. To help address this information gap, we are conducting two RCTs. The first (bronchiectasis exacerbation study; BEST-1) evaluates the efficacy of azithromycin and amoxycillin-clavulanate compared with placebo, and the second RCT (BEST-2), described here, is designed to determine if azithromycin is non-inferior to amoxycillin-clavulanate in achieving symptom resolution by day 21 of treatment in children with acute respiratory exacerbations. Australia and New Zealand Clinical Trials Register (ANZCTR) number http://ACTRN12612000010897. http://www.anzctr.org.au/trial_view.aspx?id=347879.

Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Bronchiectasis unrelated to cystic fibrosis (CF) is being increasingly recognized in children and adults globally, both in resource-poor and in affluent countries. However, high-quality evidence to inform management is scarce. Oral amoxycillin-clavulanate is often the first antibiotic chosen for non-severe respiratory exacerbations, because of the antibiotic-susceptibility patterns detected in the respiratory pathogens commonly associated with bronchiectasis. Azithromycin has a prolonged half-life, and with its unique anti-bacterial, immunomodulatory, and anti-inflammatory properties, presents an attractive alternative. Our proposed study will test the hypothesis that oral azithromycin is non-inferior (within a 20% margin) to amoxycillin-clavulanate at achieving resolution of non-severe respiratory exacerbations by day 21 of treatment in children with non-CF bronchiectasis. Methods This will be a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group trial involving six Australian and New Zealand centers. In total, 170 eligible children will be stratified by site and bronchiectasis etiology, and randomized (allocation concealed) to receive: 1) azithromycin (5 mg/kg daily) with placebo amoxycillin-clavulanate or 2) amoxycillin-clavulanate (22.5 mg/kg twice daily) with placebo azithromycin for 21 days as treatment for non-severe respiratory exacerbations. Clinical data and a parent-proxy cough-specific quality of life (PC-QOL) score will be obtained at baseline, at the start and resolution of exacerbations, and on day 21. In most children, blood and deep-nasal swabs will also be collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 21. The main secondary outcome is the PC-QOL score. Other outcomes are: time to next exacerbation; requirement for hospitalization; duration of exacerbation, and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood inflammatory markers will be reported where available. Discussion Currently, there are no published randomized controlled trials (RCT) to underpin effective, evidence-based management of acute respiratory exacerbations in children with non-CF bronchiectasis. To help address this information gap, we are conducting two RCTs. The first (bronchiectasis exacerbation study; BEST-1) evaluates the efficacy of azithromycin and amoxycillin-clavulanate compared with placebo, and the second RCT (BEST-2), described here, is designed to determine if azithromycin is non-inferior to amoxycillin-clavulanate in achieving symptom resolution by day 21 of treatment in children with acute respiratory exacerbations. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR) number http://ACTRN12612000010897. http://www.anzctr.org.au/trial_view.aspx?id=347879 PMID:23421781

Relationship authenticity partially mediates the effects of attachment on relationship satisfaction.

PubMed

Rasco, Danney; Warner, Rebecca M

2017-01-01

Individuals with anxious and avoidant attachment tend to experience less satisfaction in their relationships. Past research suggests the negative effects of attachment on relationship satisfaction may be partially mediated by self-disclosure and self-concealment; the present study evaluated relationship authenticity as a potential additional mediator. Confirmatory factor analysis indicated that relationship authenticity is distinct from self-disclosure and self-concealment. Relationship authenticity predicted additional variance in relationship satisfaction controlling for attachment, self-disclosure, and self-concealment. The results were consistent with relationship authenticity, along with self-disclosure and self-concealment, partially mediating the effects of attachment on relationship satisfaction. These findings suggest that relationship authenticity may play a unique role in understanding how attachment influences relationship satisfaction. Theoretical and clinical implications are discussed.

TT : a program that implements predictor sort design and analysis

Treesearch

S. P. Verrill; D. W. Green; V. L. Herian

1997-01-01

In studies on wood strength, researchers sometimes replace experimental unit allocation via random sampling with allocation via sorts based on nondestructive measurements of strength predictors such as modulus of elasticity and specific gravity. This report documents TT, a computer program that implements recently published methods to increase the sensitivity of such...

ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

PubMed Central

van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

2014-01-01

SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

RECAL: A Computer Program for Selecting Sample Days for Recreation Use Estimation

Treesearch

D.L. Erickson; C.J. Liu; H. Ken Cordell; W.L. Chen

1980-01-01

Recreation Calendar (RECAL) is a computer program in PL/I for drawing a sample of days for estimating recreation use. With RECAL, a sampling period of any length may be chosen; simple random, stratified random, and factorial designs can be accommodated. The program randomly allocates days to strata and locations.

Sydney Playground Project: A Cluster-Randomized Trial to Increase Physical Activity, Play, and Social Skills

ERIC Educational Resources Information Center

Bundy, Anita; Engelen, Lina; Wyver, Shirley; Tranter, Paul; Ragen, Jo; Bauman, Adrian; Baur, Louise; Schiller, Wendy; Simpson, Judy M.; Niehues, Anita N.; Perry, Gabrielle; Jessup, Glenda; Naughton, Geraldine

2017-01-01

Background: We assessed the effectiveness of a simple intervention for increasing children's physical activity, play, perceived competence/social acceptance, and social skills. Methods: A cluster-randomized controlled trial was conducted, in which schools were the clusters. Twelve Sydney (Australia) primary schools were randomly allocated to…

The Walking School Bus and children's physical activity: A pilot cluster randomized controlled trial

USDA-ARS?s Scientific Manuscript database

To evaluate the impact of a "walking school bus" program on children's rates of active commuting to school and physical activity. We conducted a pilot cluster randomized controlled trial among 4th-graders from 8 schools in Houston, Texas (N = 149). Random allocation to treatment or control condition...

A new surgical technique for concealed penis using an advanced musculocutaneous scrotal flap.

PubMed

Han, Dong-Seok; Jang, Hoon; Youn, Chang-Shik; Yuk, Seung-Mo

2015-06-19

Until recently, no single, universally accepted surgical method has existed for all types of concealed penis repairs. We describe a new surgical technique for repairing concealed penis by using an advanced musculocutaneous scrotal flap. From January 2010 to June 2014, we evaluated 12 patients (12-40 years old) with concealed penises who were surgically treated with an advanced musculocutaneous scrotal flap technique after degloving through a ventral approach. All the patients were scheduled for regular follow-up at 6, 12, and 24 weeks postoperatively. The satisfaction grade for penile size, morphology, and voiding status were evaluated using a questionnaire preoperatively and at all of the follow-ups. Information regarding complications was obtained during the postoperative hospital stay and at all follow-ups. The patients' satisfaction grades, which included the penile size, morphology, and voiding status, improved postoperatively compared to those preoperatively. All patients had penile lymphedema postoperatively; however, this disappeared within 6 weeks. There were no complications such as skin necrosis and contracture, voiding difficulty, or erectile dysfunction. Our advanced musculocutaneous scrotal flap technique for concealed penis repair is technically easy and safe. In addition, it provides a good cosmetic appearance, functional outcomes and excellent postoperative satisfaction grades. Lastly, it seems applicable in any type of concealed penis, including cases in which the ventral skin defect is difficult to cover.

Motion compensated shape error concealment.

PubMed

Schuster, Guido M; Katsaggelos, Aggelos K

2006-02-01

The introduction of Video Objects (VOs) is one of the innovations of MPEG-4. The alpha-plane of a VO defines its shape at a given instance in time and hence determines the boundary of its texture. In packet-based networks, shape, motion, and texture are subject to loss. While there has been considerable attention paid to the concealment of texture and motion errors, little has been done in the field of shape error concealment. In this paper we propose a post-processing shape error concealment technique that uses the motion compensated boundary information of the previously received alpha-plane. The proposed approach is based on matching received boundary segments in the current frame to the boundary in the previous frame. This matching is achieved by finding a maximally smooth motion vector field. After the current boundary segments are matched to the previous boundary, the missing boundary pieces are reconstructed by motion compensation. Experimental results demonstrating the performance of the proposed motion compensated shape error concealment method, and comparing it with the previously proposed weighted side matching method are presented.

Cancer survivors' concealment or disclosure of diagnosis: Implications for return to work.

PubMed

Morrison, T L; Thomas, R L

2015-01-01

The ability to return to work (RTW) is a significant quality of life indicator for many working aged cancer survivors. In the void of available support, many are left to independently navigate the RTW process which includes such important considerations as disclosure or concealment of diagnosis with concomitant sequellae. This article reviews participants' variable approaches to concealment, disclosure, or even an open educative stance as well as the associated benefits and limitations. Photovoice methods combined with interviewing. While most participants disclosed their diagnosis and many extolled the benefits of an open, educative stance, there were drawbacks experienced. Similarly, those who concealed their diagnosis also experienced benefits and challenges. In the current void of appropriate cancer rehabilitation supports, cancer survivors must independently negotiate their RTW process. Although most participants openly disclosed their diagnosis and associated limitations, a few concealed or camouflaged. There are benefits and limitations to both approaches of which survivors should be made aware at the outset as such will shape their RTW experience. Multidisciplinary rehabilitation support services would best guide survivors' management of the myriad of factors that will impact their work reintegration.

Decision Makers Use Norms, Not Cost-Benefit Analysis, When Choosing to Conceal or Reveal Unfair Rewards

PubMed Central

Heimann, Marco; Girotto, Vittorio; Legrenzi, Paolo; Bonnefon, Jean-François

2013-01-01

We introduce the Conceal or Reveal Dilemma, in which individuals receive unfair benefits, and must decide whether to conceal or to reveal this unfair advantage. This dilemma has two important characteristics: it does not lend itself easily to cost-benefit analysis, neither to the application of any strong universal norm. As a consequence, it is ideally suited to the study of interindividual and intercultural variations in moral-economic norms. In this paper we focus on interindividual variations, and we report four studies showing that individuals cannot be swayed by financial incentives to conceal or to reveal, and follow instead fixed, idiosyncratic strategies. We discuss how this result can be extended to individual and cultural variations in the tendency to display or to hide unfair rewards. PMID:24066040

Decision makers use norms, not cost-benefit analysis, when choosing to conceal or reveal unfair rewards.

PubMed

Heimann, Marco; Girotto, Vittorio; Legrenzi, Paolo; Bonnefon, Jean-François

2013-01-01

We introduce the Conceal or Reveal Dilemma, in which individuals receive unfair benefits, and must decide whether to conceal or to reveal this unfair advantage. This dilemma has two important characteristics: it does not lend itself easily to cost-benefit analysis, neither to the application of any strong universal norm. As a consequence, it is ideally suited to the study of interindividual and intercultural variations in moral-economic norms. In this paper we focus on interindividual variations, and we report four studies showing that individuals cannot be swayed by financial incentives to conceal or to reveal, and follow instead fixed, idiosyncratic strategies. We discuss how this result can be extended to individual and cultural variations in the tendency to display or to hide unfair rewards.

Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis

PubMed Central

Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

2017-01-01

Background MIGS have been developed as a surgical alternative for glaucomatous patients. Purpose To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Methods Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Results Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients’ selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Conclusions Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted. PMID:28850575

Momordica charantia for type 2 diabetes mellitus.

PubMed

Ooi, Cheow Peng; Yassin, Zaitun; Hamid, Tengku-Aizan

2010-02-17

Momordica charantia is not only a nutritious vegetable, but is also used in traditional medical practices to treat type 2 diabetes mellitus. Experimental studies with animals and humans suggested that the vegetable has a possible role in glycaemic control. To assess the effects of mormodica charantia for type 2 diabetes mellitus. Several electronic databases were searched, among these The Cochrane Library (issue 4, 2009), MEDLINE, EMBASE, CINAHL, SIGLE and LILACS (all up to November 2009), combined with handsearches. No language restriction was used. Randomized controlled trials that compared momordica charantia with a placebo or a control intervention with or without pharmacological or non-pharmacological interventions were included. Two authors independently extracted the data. Risk of bias of trials was evaluated using the parameters of randomization, allocation concealment, blinding, completeness of outcome data, selective reporting and other potential sources of bias. A meta-analysis was not performed given the quality of data and the variability of preparations of momordica charantia used in interventions (no similar preparation was tested twice). Three randomised controlled trials with up to three months duration and investigating 350 participants met the inclusion criteria. Risk of bias of these trials (only one study was published as a full peer-reviewed publication) was generally high. Two RCTs compared the effect of preparations from different parts of the momordica charantia plants and placebo on the glycemic control in type 2 diabetes mellitus. There was no statistically significant difference compared to placebo. The effects of preparation from the leaves of the plant and glibenclamide were comparable in the third trial. No serious adverse effects were reported in all the trials. There were no documentations of death from any cause, morbidity, (health-related) quality of life and costs. There is insufficient evidence to recommend momordica charantia for type 2 diabetes mellitus. Further studies are therefore required to address the issues of standardization and the quality control of preparations. For medical nutritional therapy, further observational trials evaluating the effects of momordica charantia are needed before RCTs are established to guide any recommendations in clinical practice.

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

PubMed Central

2010-01-01

Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). Discussion This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. Trial Registration Current controlled trial ISRCTN54009836 PMID:20398349

Impact of contact on adolescents' mental health literacy and stigma: the SchoolSpace cluster randomised controlled trial.

PubMed

Chisholm, Katharine; Patterson, Paul; Torgerson, Carole; Turner, Erin; Jenkinson, David; Birchwood, Max

2016-02-19

To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. Secondary schools in Birmingham, UK. The parents and guardians of all students in year 8 (age 12-13 years) were approached to take part. A 1-day educational programme in each school led by mental health professional staff. Students in the 'contact' condition received an interactive session with a young person with lived experience of mental illness. The primary outcome was students' attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Participants were recruited between 1 May 2011 and 30 April 2012. 769 participants completed the pretest and were randomised to condition. 657 (85%) provided follow-up data. At 2-week follow-up, attitudinal stigma improved in both conditions with no significant effect of condition (95% CI -0.40 to 0.22, p=0.5, d=0.01). Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Contact was found to reduce the impact of the intervention for a number of outcomes. Caution is advised before employing intergroup contact with younger student age groups. The education intervention appeared to be successful in reducing stigma, promoting mental health knowledge, and increasing mental health literacy, as well as improving emotional well-being and resilience. A larger trial is needed to confirm these results. ISRCTN07406026; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Impact of contact on adolescents’ mental health literacy and stigma: the SchoolSpace cluster randomised controlled trial

PubMed Central

Chisholm, Katharine; Patterson, Paul; Torgerson, Carole; Turner, Erin; Jenkinson, David; Birchwood, Max

2016-01-01

Objectives To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. Design A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. Setting Secondary schools in Birmingham, UK. Participants The parents and guardians of all students in year 8 (age 12–13 years) were approached to take part. Interventions A 1-day educational programme in each school led by mental health professional staff. Students in the ‘contact’ condition received an interactive session with a young person with lived experience of mental illness. Outcomes The primary outcome was students’ attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Results Participants were recruited between 1 May 2011 and 30 April 2012. 769 participants completed the pretest and were randomised to condition. 657 (85%) provided follow-up data. At 2-week follow-up, attitudinal stigma improved in both conditions with no significant effect of condition (95% CI −0.40 to 0.22, p=0.5, d=0.01). Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Conclusions Contact was found to reduce the impact of the intervention for a number of outcomes. Caution is advised before employing intergroup contact with younger student age groups. The education intervention appeared to be successful in reducing stigma, promoting mental health knowledge, and increasing mental health literacy, as well as improving emotional well-being and resilience. A larger trial is needed to confirm these results. Trial registration number ISRCTN07406026; Results. PMID:26895983

Long-term outcome of early interventions to prevent posttraumatic stress disorder.

PubMed

Shalev, Arieh Y; Ankri, Yael; Gilad, Moran; Israeli-Shalev, Yossi; Adessky, Rhonda; Qian, Meng; Freedman, Sara

2016-05-01

Failing to prevent posttraumatic stress disorder (PTSD) has major clinical and public health consequences. This work evaluates the 3-year outcome of offering early interventions to survivors with acute PTSD. Adults admitted consecutively to the hospital with acute DSM-IV PTSD were randomized, between June 2003 and October 2007, to 12 weeks of prolonged exposure (n = 63) or cognitive therapy (n = 40) or concealed SSRI (escitalopram; n = 23) versus placebo (n = 23). Eighty-two participants who declined treatment were followed as well. Treatment started 1 month after the traumatic event, and participants were reassessed 5 and 36 months later. Assessors were blinded to treatment allocation and acceptance. The Clinician-Administered PTSD Scale (CAPS) evaluated PTSD and PTSD symptoms. Self-reported symptoms, general functioning, and employment status were secondary outcomes. Participants lost to follow-up were missing completely at random. Prolonged exposure and cognitive therapy significantly reduced PTSD and PTSD symptoms between 1 and 5 months (mean CAPS total scores [95% CI] at 1 month: prolonged exposure = 73.59 [68.21-78.96] and cognitive therapy = 71.78 [66.92-78.93]; mean CAPS total scores [95% CI] at 5 months: prolonged exposure = 28.59 [21.89-35.29] and cognitive therapy = 29.48 [21.32-37.95], P < .001), and their results remained stable. At 3 years, however, the study groups had similar levels of PTSD symptoms (mean CAPS total scores [95% CI]: prolonged exposure = 31.51 [20.25-42.78]; cognitive therapy = 32.08 [20.74-43.42]; SSRI = 34.31 [16.54-52.07]; placebo = 32.13 [20.15-44.12]; and no intervention = 30.59 [19.40-41.78]), similar prevalence of PTSD (28.6%-46.2%), and similar secondary outcomes. Early prolonged exposure and cognitive therapy accelerated the recovery from acute PTSD. Their effect remained stable, however, without reducing the 3-year prevalence of the disorder. The lingering prevalence of PTSD, despite efficient interventions, illustrates a nonremitting, treatment-refractory subset of survivors and outlines a major clinical and public health challenge. ClinicalTrials.gov identifier: NCT00146900. © Copyright 2016 Physicians Postgraduate Press, Inc.

Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial.

PubMed

Bell, Susan P; Schnipper, Jeffrey L; Goggins, Kathryn; Bian, Aihua; Shintani, Ayumi; Roumie, Christianne L; Dalal, Anuj K; Jacobson, Terry A; Rask, Kimberly J; Vaccarino, Viola; Gandhi, Tejal K; Labonville, Stephanie A; Johnson, Daniel; Neal, Erin B; Kripalani, Sunil

2016-05-01

Reduction in 30-day readmission rates following hospitalization for acute coronary syndrome (ACS) and acute decompensated heart failure (ADHF) is a national goal. The aim of this study was to determine the effect of a tailored, pharmacist-delivered, health literacy intervention on unplanned health care utilization, including hospital readmission or emergency room (ER) visit, following discharge. Randomized, controlled trial with concealed allocation and blinded outcome assessors Two tertiary care academic medical centers Adults hospitalized with a diagnosis of ACS and/or ADHF. Pharmacist-assisted medication reconciliation, inpatient pharmacist counseling, low-literacy adherence aids, and individualized telephone follow-up after discharge The primary outcome was time to first unplanned health care event, defined as hospital readmission or an ER visit within 30 days of discharge. Pre-specified analyses were conducted to evaluate the effects of the intervention by academic site, health literacy status (inadequate versus adequate), and cognition (impaired versus not impaired). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) are reported. A total of 851 participants enrolled in the study at Vanderbilt University Hospital (VUH) and Brigham and Women's Hospital (BWH). The primary analysis showed no statistically significant effect on time to first unplanned hospital readmission or ER visit among patients who received interventions compared to controls (aHR = 1.04, 95% CI 0.78-1.39). There was an interaction of treatment effect by site (p = 0.04 for interaction); VUH aHR = 0.77, 95% CI 0.51-1.15; BWH aHR = 1.44 (95% CI 0.95-2.12). The intervention reduced early unplanned health care utilization among patients with inadequate health literacy (aHR 0.41, 95% CI 0.17-1.00). There was no difference in treatment effect by patient cognition. A tailored, pharmacist-delivered health literacy-sensitive intervention did not reduce post-discharge unplanned health care utilization overall. The intervention was effective among patients with inadequate health literacy, suggesting that targeted practice of pharmacist intervention in this population may be advantageous.

Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

PubMed Central

2010-01-01

Background Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame) format is associated with a better reporting quality of randomized controlled trials (RCTs). Methods We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1) a 14-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials; and 2) a 3-point key score (KS), based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model. Results A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR) = 1.021, 95% CI: 1.012 to 1.029) and KS (IRR = 1.142, 95% CI: 1.079 to 1.210). A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132) and KS (IRR = 1.530, 95% CI 1.311-1.786). Conclusions Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect is small - and better reporting of key methodologies. PMID:20137069

Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis.

PubMed

Lavia, Carlo; Dallorto, Laura; Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

2017-01-01

MIGS have been developed as a surgical alternative for glaucomatous patients. To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial.

PubMed

Perissinotto, Maria Carolina; DʼAncona, Carlos Arturo Levi; Lucio, Adélia; Campos, Renata Martins; Abreu, Anelyssa

2015-01-01

A randomized controlled trial study was performed to evaluate the efficacy of transcutaneous tibial nerve stimulation (TTNS) and sham TTNS, in patients with Parkinson disease (PD) with lower urinary tract symptoms (LUTS). Randomized controlled trial. Thirteen patients with a diagnosis of PD and bothersome LUTS were randomly allocated to one of the following groups: Group I: TTNS group (n = 8) and group II: Sham group (n = 5). Both groups attended twice a week during 5 weeks; each session lasted 30 minutes. Eight patients received TTNS treatment and 5 subjects allocated to group II were managed with sham surface electrodes that delivered no electrical stimulation. Assessments were performed before and after the treatment; they included a 3-day bladder diary, Overactive Bladder Questionnaire (OAB-V8), and the International Consultation on Incontinence Quality of Life Questionnaire Short Form (ICIQ-SF), and urodynamic evaluation. Following 5 weeks of treatment, patients allocated to TTNS demonstrated statistically significant reductions in the number of urgency episodes (P = .004) and reductions in nocturia episodes (P < .01). Participants allocated to active treatment also showed better results after treatment in the OAB-V8 and ICIQ-SF scores (P < .01, respectively). Urodynamic testing revealed that patients in the active treatment group showed improvements in intravesical volume at strong desire to void (P < .05) and volume at urgency (P < .01) when compared to subjects in the sham treatment group. These findings suggest that TTNS is effective in the treatment of LUTS in patients with PD, reducing urgency and nocturia episodes and improving urodynamic parameters as well as symptom scores measured by the OAB-V8 and health-related quality-of-life scores measured by the ICIQ-SF.

Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

PubMed Central

Bennell, Kim; Coburn, Sally; Wee, Elin; Green, Sally; Harris, Anthony; Forbes, Andrew; Buchbinder, Rachelle

2007-01-01

Background Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness. Methods/Design This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor monthly. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Participant measures of perceived change will be compared between groups by calculating the relative risks and their 95% confidence intervals at each time point using log binomial regression. Discussion Results from this trial will contribute to the evidence regarding the effectiveness of a physiotherapy program for the management of CRCP. Trial registration NIH Clinical Trials Registry # NCT00415441 PMID:17761004

Effectiveness of functional hand splinting and the cognitive orientation to occupational performance (CO-OP) approach in children with cerebral palsy and brain injury: two randomised controlled trial protocols

PubMed Central

2014-01-01

Background Cerebral palsy (CP) and brain injury (BI) are common conditions that have devastating effects on a child’s ability to use their hands. Hand splinting and task-specific training are two interventions that are often used to address deficits in upper limb skills, both in isolation or concurrently. The aim of this paper is to describe the method to be used to conduct two randomised controlled trials (RCT) investigating (a) the immediate effect of functional hand splints, and (b) the effect of functional hand splints used concurrently with task-specific training compared to functional hand splints alone, and to task-specific training alone in children with CP and BI. The Cognitive Orientation to Occupational Performance (CO-OP) approach will be the task-specific training approach used. Methods/Design Two concurrent trials; a two group, parallel design, RCT with a sample size of 30 participants (15 per group); and a three group, parallel design, assessor blinded, RCT with a sample size of 45 participants (15 per group). Inclusion criteria: age 4-15 years; diagnosis of CP or BI; Manual Abilities Classification System (MACS) level I – IV; hand function goals; impaired hand function; the cognitive, language and behavioural ability to participate in CO-OP. Participants will be randomly allocated to one of 3 groups; (1) functional hand splint only (n=15); (2) functional hand splint combined with task-specific training (n=15); (3) task-specific training only (n=15). Allocation concealment will be achieved using sequentially numbered, sealed opaque envelopes opened by an off-site officer after baseline measures. Treatment will be provided for a period of 2 weeks, with outcome measures taken at baseline, 1 hour after randomisation, 2 weeks and 10 weeks. The functional hand splint will be a wrist cock-up splint (+/- thumb support or supination strap). Task-specific training will involve 10 sessions of CO-OP provided in a group of 2-4 children. Primary outcome measures will be the Canadian Occupational Performance Measure (COPM) and the Goal Attainment Scale (GAS). Analysis will be conducted on an intention-to-treat basis. Discussion This paper outlines the protocol for two randomised controlled trials investigating functional hand splints and CO-OP for children with CP and BI. PMID:25023385

Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison

PubMed Central

Coombes, Brooke K; Bisset, Leanne; Connelly, Luke B; Brooks, Peter; Vicenzino, Bill

2009-01-01

Background Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a non-inflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues. Methods A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, cost-effectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression models. Healthcare costs will be collected from a societal perspective, and along with willingness-to-pay and quality of life data will facilitate cost-effectiveness and cost-benefit analyses. Conclusion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. Findings from this study will assist in the development of evidence based practice recommendations and potentially the optimisation of resource allocation for rehabilitating lateral epicondylalgia. Trial registration Australian New Zealand Clinical Trials Register ACTRN12609000051246 PMID:19552805

The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review

PubMed Central

Free, Caroline; Phillips, Gemma; Galli, Leandro; Watson, Louise; Felix, Lambert; Edwards, Phil; Patel, Vikram; Haines, Andy

2013-01-01

Background Mobile technologies could be a powerful media for providing individual level support to health care consumers. We conducted a systematic review to assess the effectiveness of mobile technology interventions delivered to health care consumers. Methods and Findings We searched for all controlled trials of mobile technology-based health interventions delivered to health care consumers using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990–Sept 2010). Two authors extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and used random effects meta-analysis. We identified 75 trials. Fifty-nine trials investigated the use of mobile technologies to improve disease management and 26 trials investigated their use to change health behaviours. Nearly all trials were conducted in high-income countries. Four trials had a low risk of bias. Two trials of disease management had low risk of bias; in one, antiretroviral (ART) adherence, use of text messages reduced high viral load (>400 copies), with a relative risk (RR) of 0.85 (95% CI 0.72–0.99), but no statistically significant benefit on mortality (RR 0.79 [95% CI 0.47–1.32]). In a second, a PDA based intervention increased scores for perceived self care agency in lung transplant patients. Two trials of health behaviour management had low risk of bias. The pooled effect of text messaging smoking cessation support on biochemically verified smoking cessation was (RR 2.16 [95% CI 1.77–2.62]). Interventions for other conditions showed suggestive benefits in some cases, but the results were not consistent. No evidence of publication bias was demonstrated on visual or statistical examination of the funnel plots for either disease management or health behaviours. To address the limitation of the older search, we also reviewed more recent literature. Conclusions Text messaging interventions increased adherence to ART and smoking cessation and should be considered for inclusion in services. Although there is suggestive evidence of benefit in some other areas, high quality adequately powered trials of optimised interventions are required to evaluate effects on objective outcomes. Please see later in the article for the Editors' Summary PMID:23349621

Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study.

PubMed

Montedori, Alessandro; Bonacini, Maria Isabella; Casazza, Giovanni; Luchetta, Maria Laura; Duca, Piergiorgio; Cozzolino, Francesco; Abraha, Iosief

2011-02-28

Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat. To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Trials were categorized based on the "type" of intention-to-treat reporting as follows: ITT, trials reporting the use of standard ITT approach; mITT, trials reporting the use of a "modified intention-to-treat" approach; and "no ITT", trials not reporting the use of any intention-to-treat approach. Two pairs of reviewers independently extracted the data in duplicate. The strength of the associations between the "type" of intention-to-treat reporting and the quality of reporting (sample size calculation, flow-chart, lost to follow-up), the methodological quality of the trials (sequence generation, allocation concealment, and blinding), the funding source, and the findings was determined. Odds ratios (OR) were calculated with 95% confidence intervals (CI). Of the 367 RCTs included, 197 were classified as ITT, 56 as mITT, and 114 as "no ITT" trials. The quality of reporting and the methodological quality of the mITT trials were similar to those of the ITT trials; however, the mITT trials were more likely to report post-randomization exclusions (adjusted OR 3.43 [95%CI, 1.70 to 6.95]; P < 0.001). We found a strong association between trials classified as mITT and for-profit agency sponsorship (adjusted OR 7.41 [95%CI, 3.14 to 17.48]; P < .001) as well as the presence of authors' conflicts of interest (adjusted OR 5.14 [95%CI, 2.12 to 12.48]; P < .001). There was no association between mITT reporting and favourable results; in general, however, trials with for-profit agency sponsorship were significantly associated with favourable results (adjusted OR 2.30; [95%CI, 1.28 to 4.16]; P = 0.006). We found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.

Small threat and contraband detection with TNA-based systems.

PubMed

Shaw, T J; Brown, D; D'Arcy, J; Liu, F; Shea, P; Sivakumar, M; Gozani, T

2005-01-01

The detection of small threats, such as explosives, drugs, and chemical weapons, concealed or encased in surrounding material, is a major concern in areas from security checkpoints to UneXploded Ordnance (UXO) clearance. Techniques such as X-ray and trace detection are often ineffectual in these applications. Thermal neutron analysis (TNA) provides an effective method for detecting concealed threats. This paper shows the effectiveness of Ancore's SPEDS, based on TNA, in detecting concealed liquid threats and differentiating live from inert mortar shells.

Examining farmers' willingness to grow and allocate land for oilseed crops for biofuel production

USDA-ARS?s Scientific Manuscript database

The purpose of this paper is to determine farmers’ willingness to adopt and allocate land for growing non-food oilseeds as bio-energy crops across the western US. A mail survey was conducted in three regions of the western US from randomly selected wheat farmers. Data was analyzed using Heckman’s tw...

Deservingness and Equality in Children's Reward Allocations: Developmental Trends.

ERIC Educational Resources Information Center

Kaplan, Martin F.; Yehl, H. Michael

A total of 96 students (16 males and 16 females, chosen randomly from each of the first, fourth, and seventh grades of a grade school and a middle school,) allocated rewards in response to stimuli representing pairs of children differing in work output and effort. Stimulus materials consisted of: (1) a booklet containing nine drawings representing…

Predictor sort sampling, tight t`s, and the analysis of covariance : theory, tables, and examples

Treesearch

S. P. Verrill; D. W. Green

In recent years wood strength researchers have begun to replace experimental unit allocation via random sampling with allocation via sorts based on nondestructive measurements of strength predictors such as modulus of elasticity and specific gravity. Although this procedure has the potential of greatly increasing experimental sensitivity, as currently implemented it...

Resource Allocation and Time Utilization in IGE and Non-IGE Schools. Technical Paper No. 410.

ERIC Educational Resources Information Center

Rossmiller, Richard A.; Geske, Terry G.

This study addressed two basic questions; (1) Do individually guided education (IGE) schools cost more or exhibit different expenditure patterns than non-IGE schools? (2) Do instructional personnel in IGE schools allocate their time differently than instructional personnel in non-IGE schools? Data were obtained from a random sample of 41 IGE…

Investigating expectation effects using multiple physiological measures

PubMed Central

Siller, Alexander; Ambach, Wolfgang; Vaitl, Dieter

2015-01-01

The study aimed at experimentally investigating whether the human body can anticipate future events under improved methodological conditions. Previous studies have reported contradictory results for the phenomenon typically called presentiment. If the positive findings are accurate, they call into doubt our views about human perception, and if they are inaccurate, a plausible conventional explanation might be based on the experimental design of the previous studies, in which expectation due to item sequences was misinterpreted as presentiment. To address these points, we opted to collect several physiological variables, to test different randomization types and to manipulate subjective significance individually. For the latter, we combined a mock crime scenario, in which participants had to steal specific items, with a concealed information test (CIT), in which the participants had to conceal their knowledge when interrogated about items they had stolen or not stolen. We measured electrodermal activity, respiration, finger pulse, heart rate (HR), and reaction times. The participants (n = 154) were assigned randomly to four different groups. Items presented in the CIT were either drawn with replacement (full) or without replacement (pseudo) and were either presented category-wise (cat) or regardless of categories (nocat). To understand how these item sequences influence expectation and modulate physiological reactions, we compared the groups with respect to effect sizes for stolen vs. not stolen items. Group pseudo_cat yielded the highest effect sizes, and pseudo_nocat yielded the lowest. We could not find any evidence of presentiment but did find evidence of physiological correlates of expectation. Due to the design differing fundamentally from previous studies, these findings do not allow for conclusions on the question whether the expectation bias is being confounded with presentiment. PMID:26500600

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

PubMed

Galante, Julieta; Dufour, Géraldine; Vainre, Maris; Wagner, Adam P; Stochl, Jan; Benton, Alice; Lathia, Neal; Howarth, Emma; Jones, Peter B

2018-02-01

The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE-OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE-OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference -0·14, 95% CI -0·22 to -0·06; p=0·001), showing a moderate effect size (β -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Targeted case finding for chronic obstructive pulmonary disease versus routine practice in primary care (TargetCOPD): a cluster-randomised controlled trial.

PubMed

Jordan, Rachel E; Adab, Peymané; Sitch, Alice; Enocson, Alexandra; Blissett, Deirdre; Jowett, Sue; Marsh, Jen; Riley, Richard D; Miller, Martin R; Cooper, Brendan G; Turner, Alice M; Jolly, Kate; Ayres, Jon G; Haroon, Shamil; Stockley, Robert; Greenfield, Sheila; Siebert, Stanley; Daley, Amanda J; Cheng, K K; Fitzmaurice, David

2016-09-01

Many individuals with chronic obstructive pulmonary disease (COPD) remain undiagnosed worldwide. Health-care organisations are implementing case-finding programmes without good evidence of which are the most effective and cost-effective approaches. We assessed the effectiveness and cost-effectiveness of two alternative approaches to targeted case finding for COPD compared with routine practice. In this cluster-randomised controlled trial, participating general practices in the West Midlands, UK, were randomly assigned (1:1), via a computer-generated block randomisation sequence, to either a targeted case-finding group or a routine care group. Eligible patients were ever-smokers aged 40-79 years without a previously recorded diagnosis of COPD. Patients in the targeted case-finding group were further randomly assigned (1:1) via their household to receive either a screening questionnaire at the general practitioner (GP) consultation (opportunistic) or a screening questionnaire at the GP consultation plus a mailed questionnaire (active). Respondents reporting relevant respiratory symptoms were invited for post-bronchodilator spirometry. Patients, clinicians, and investigators were not masked to allocation, but group allocation was concealed from the researchers who performed the spirometry assessments. Primary outcomes were the percentage of the eligible population diagnosed with COPD within 1 year (defined as post-bronchodilator forced expiratory volume in 1 s [FEV1] to forced vital capacity [FVC] ratio <0·7 in patients with symptoms or a new diagnosis on their GP record) and cost per new COPD diagnosis. Multiple logistic and Poisson regression were used to estimate effect sizes. Costs were obtained from the trial. This trial is registered with ISRCTN, number ISRCTN14930255. From Aug 10, 2012, to June 22, 2014, 74 818 eligible patients from 54 diverse general practices were randomly assigned and completed the trial. At 1 year, 1278 (4%) cases of COPD were newly detected in 32 789 eligible patients in the targeted case-finding group compared with 337 (1%) cases in 42 029 patients in the routine care group (adjusted odds ratio [OR] 7·45 [95% CI 4·80-11·55], p<0·0001). The percentage of newly detected COPD cases was higher in the active case-finding group (822 [5%] of 15 378) than in the opportunistic case-finding group (370 [2%] of 15 387; adjusted OR 2·34 [2·06-2·66], p<0·0001; adjusted risk difference 2·9 per 100 patients [95% CI 2·3-3·6], p<0·0001). Active case finding was more cost-effective than opportunistic case finding (£333 vs £376 per case detected, respectively). In this well established primary care system, routine practice identified few new cases of COPD. An active targeted approach to case finding including mailed screening questionnaires before spirometry is a cost-effective way to identify undiagnosed patients and has the potential to improve their health. National Institute for Health Research. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Effect of IV Amino Acid Supplementation on Mortality in ICU Patients May Be Dependent on Kidney Function: Post Hoc Subgroup Analyses of a Multicenter Randomized Trial.

PubMed

Zhu, Ran; Allingstrup, Matilde J; Perner, Anders; Doig, Gordon S

2018-05-15

We investigated whether preexisting kidney function determines if ICU patients may benefit from increased (2.0 g/kg/d) protein intake. Post hoc, hypothesis-generating, subgroup analysis of a multicenter, phase 2, randomized clinical trial. All analyses were conducted by intention to treat and maintained group allocation. Ninety-day mortality was the primary outcome. ICUs of 16 hospitals throughout Australia and New Zealand. Adult critically ill patients expected to remain in the study ICU for longer than 2 days. Random allocation to receive a daily supplement of up to 100 g of IV amino acids to achieve a total protein intake of 2.0 g/kg/d or standard nutrition care. A total of 474 patients were randomized: 235 to standard care and 239 to IV amino acid supplementation. There was a statistically significant interaction between baseline kidney function and supplementation with study amino acids (p value for interaction = 0.026). Within the subgroup of patients with normal kidney function at randomization, patients who were allocated to receive the study amino acid supplement were less likely to die before study day 90 (covariate-adjusted risk difference, -7.9%; 95% CI, -15.1 to -0.7; p = 0.034). Furthermore, amino acid supplementation significantly increased estimated glomerular filtration rate in these patients (repeated-measures treatment × time interaction p = 0.009). Within the subgroup of patients with baseline kidney dysfunction and/or risk of progression of acute kidney injury, a significant effect of the study intervention on mortality was not found (covariate-adjusted risk difference, -0.6%; 95% CI, -16.2 to 15.2; p = 0.95). In this post hoc, hypothesis-generating, subgroup analysis, we observed reduced mortality and improved estimated glomerular filtration rate in ICU patients with normal kidney function who were randomly allocated to receive increased protein intake (up to 2.0 g/kg/d). We strongly recommend confirmation of these results in trials with low risk of bias before this treatment is recommended for routine care.

An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results.

PubMed

Boezeman, Edwin J; Nieuwenhuijsen, Karen; Sluiter, Judith K

2018-06-01

The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress.

A distributed scheduling algorithm for heterogeneous real-time systems

NASA Technical Reports Server (NTRS)

Zeineldine, Osman; El-Toweissy, Mohamed; Mukkamala, Ravi

1991-01-01

Much of the previous work on load balancing and scheduling in distributed environments was concerned with homogeneous systems and homogeneous loads. Several of the results indicated that random policies are as effective as other more complex load allocation policies. The effects of heterogeneity on scheduling algorithms for hard real time systems is examined. A distributed scheduler specifically to handle heterogeneities in both nodes and node traffic is proposed. The performance of the algorithm is measured in terms of the percentage of jobs discarded. While a random task allocation is very sensitive to heterogeneities, the algorithm is shown to be robust to such non-uniformities in system components and load.

Pseudo-random dynamic address configuration (PRDAC) algorithm for mobile ad hoc networks

NASA Astrophysics Data System (ADS)

Wu, Shaochuan; Tan, Xuezhi

2007-11-01

By analyzing all kinds of address configuration algorithms, this paper provides a new pseudo-random dynamic address configuration (PRDAC) algorithm for mobile ad hoc networks. Based on PRDAC, the first node that initials this network randomly chooses a nonlinear shift register that can generates an m-sequence. When another node joins this network, the initial node will act as an IP address configuration sever to compute an IP address according to this nonlinear shift register, and then allocates this address and tell the generator polynomial of this shift register to this new node. By this means, when other node joins this network, any node that has obtained an IP address can act as a server to allocate address to this new node. PRDAC can also efficiently avoid IP conflicts and deal with network partition and merge as same as prophet address (PA) allocation and dynamic configuration and distribution protocol (DCDP). Furthermore, PRDAC has less algorithm complexity, less computational complexity and more sufficient assumption than PA. In addition, PRDAC radically avoids address conflicts and maximizes the utilization rate of IP addresses. Analysis and simulation results show that PRDAC has rapid convergence, low overhead and immune from topological structures.

A multi-assets artificial stock market with zero-intelligence traders

NASA Astrophysics Data System (ADS)

Ponta, L.; Raberto, M.; Cincotti, S.

2011-01-01

In this paper, a multi-assets artificial financial market populated by zero-intelligence traders with finite financial resources is presented. The market is characterized by different types of stocks representing firms operating in different sectors of the economy. Zero-intelligence traders follow a random allocation strategy which is constrained by finite resources, past market volatility and allocation universe. Within this framework, stock price processes exhibit volatility clustering, fat-tailed distribution of returns and reversion to the mean. Moreover, the cross-correlations between returns of different stocks are studied using methods of random matrix theory. The probability distribution of eigenvalues of the cross-correlation matrix shows the presence of outliers, similar to those recently observed on real data for business sectors. It is worth noting that business sectors have been recovered in our framework without dividends as only consequence of random restrictions on the allocation universe of zero-intelligence traders. Furthermore, in the presence of dividend-paying stocks and in the case of cash inflow added to the market, the artificial stock market points out the same structural results obtained in the simulation without dividends. These results suggest a significative structural influence on statistical properties of multi-assets stock market.

Knowledge of display rules in prelingually deaf and hearing children.

PubMed

Hosie, J A; Russell, P A; Gray, C D; Scott, C; Hunter, N; Banks, J S; Macaulay, M C

2000-03-01

Deaf children of elementary and secondary school age participated in a study designed to examine their understanding of display rules, the principles governing the expression and concealment of emotion in social situations. The results showed that deaf children's knowledge of display rules, as measured by their reported concealment of emotion, was comparable to that of hearing children of the same age. However, deaf children were less likely to report that they would conceal happiness and anger. They were also less likely to produce reasons for concealing emotion and a smaller proportion of their reasons were prosocial, that is, relating to the feelings of others. The results suggest that the understanding of display rules (which function to protect the feelings of other people) may develop more gradually in deaf children raised in a spoken language environment than it does in hearing children.

Determinants of felt stigma in epilepsy.

PubMed

Aydemir, N; Kaya, B; Yıldız, G; Öztura, I; Baklan, B

2016-05-01

The present study aimed to determine the level of felt stigma, overprotection, concealment, and concerns related to epilepsy in different life domains by using culturally-specific scales for Turkish individuals with epilepsy. Also, it aimed to detect relations among the study variables and to determine the variables which predict felt stigma. For this purpose, felt stigma scale, overprotection scale, concealment of epilepsy scale, and concerns of epilepsy scale were administered to two hundred adult persons with epilepsy (PWE). The results showed that almost half of the participants reported felt stigma, overprotection, concealment of epilepsy, concerns related to future occupation, and concerns related to social life. Almost all the study variables show correlations with each other. Concealment of epilepsy, concerns related to social life, and concerns related to future occupation were found as the predictors of felt stigma. Copyright © 2016 Elsevier Inc. All rights reserved.

Parasitism rate, parasitoid community composition and host specificity on exposed and semi-concealed caterpillars from a tropical rainforest.

PubMed

Hrcek, Jan; Miller, Scott E; Whitfield, James B; Shima, Hiroshi; Novotny, Vojtech

2013-10-01

The processes maintaining the enormous diversity of herbivore-parasitoid food webs depend on parasitism rate and parasitoid host specificity. The two parameters have to be evaluated in concert to make conclusions about the importance of parasitoids as natural enemies and guide biological control. We document parasitism rate and host specificity in a highly diverse caterpillar-parasitoid food web encompassing 266 species of lepidopteran hosts and 172 species of hymenopteran or dipteran parasitoids from a lowland tropical forest in Papua New Guinea. We found that semi-concealed hosts (leaf rollers and leaf tiers) represented 84% of all caterpillars, suffered a higher parasitism rate than exposed caterpillars (12 vs. 5%) and their parasitoids were also more host specific. Semi-concealed hosts may therefore be generally more amenable to biological control by parasitoids than exposed ones. Parasitoid host specificity was highest in Braconidae, lower in Diptera: Tachinidae, and, unexpectedly, the lowest in Ichneumonidae. This result challenges the long-standing view of low host specificity in caterpillar-attacking Tachinidae and suggests higher suitability of Braconidae and lower suitability of Ichneumonidae for biological control of caterpillars. Semi-concealed hosts and their parasitoids are the largest, yet understudied component of caterpillar-parasitoid food webs. However, they still remain much closer in parasitism patterns to exposed hosts than to what literature reports on fully concealed leaf miners. Specifically, semi-concealed hosts keep an equally low share of idiobionts (2%) as exposed caterpillars.

Principles of scarce medical resource allocation in natural disaster relief: a simulation approach.

PubMed

Cao, Hui; Huang, Simin

2012-01-01

A variety of triage principles have been proposed. The authors sought to evaluate their effects on how many lives can be saved in a hypothetical disaster. To determine an optimal scarce resource-rationing principle in the emergency response domain, considering the trade-off between lifesaving efficiency and ethical issues. A discrete event simulation model is developed to examine the efficiency of four resource-rationing principles: first come-first served, random, most serious first, and least serious first. Seven combinations of available resources are examined in the simulations to evaluate the performance of the principles under different levels of resource scarcity. The simulation results indicate that the performance of the medical resource allocation principles is related to the level of the resource scarcity. When the level of the scarcity is high, the performances of the four principles differ significantly. The least serious first principle performs best, followed by the random principle; the most serious first principle acts worst. However, when the scarcity is relieved, there are no significant differences among the random, first come-first served, and least serious first principles, yet the most serious first principle still performs worst. Although the least serious first principle exhibits the highest efficiency, it is not ethically flawless. Considering the trade off between the lifesaving efficiency and the ethical issues, random selection is a relatively fair and efficient principle for allocating scarce medical resources in natural disaster responses.

Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial.

PubMed

Blyth, Annie; Maskrey, Vivienne; Notley, Caitlin; Barton, Garry R; Brown, Tracey J; Aveyard, Paul; Holland, Richard; Bachmann, Max O; Sutton, Stephen; Leonardi-Bee, Jo; Brandon, Thomas H; Song, Fujian

2015-07-01

Most people who quit smoking successfully for a short period will return to smoking again in 12 months. A previous exploratory meta-analysis indicated that self-help booklets may be effective for smoking relapse prevention in unaided quitters. This study aimed to evaluate the effectiveness of a set of self-help educational booklets to prevent smoking relapse in people who had stopped smoking with the aid of behavioural support. This is an open, randomised controlled trial and qualitative process evaluation. Trial participants were randomly allocated to one of two groups, using a simple randomisation process without attempts to stratify by participant characteristics. The participant allocation was 'concealed' because the recruitment of quitters occurred before the random allocation. Short-term quitters were recruited from NHS Stop Smoking Clinics, and self-help educational materials were posted to study participants at home. A total of 1407 carbon monoxide (CO)-validated quitters at 4 weeks after quit date in NHS Stop Smoking Clinics. The trial excluded pregnant women and quitters who were not able to read the educational materials in English. Participants in the experimental group (n = 703) received a set of eight revised Forever Free booklets, and participants in the control group (n = 704) received a single leaflet that is currently given to NHS patients. Follow-up telephone interviews were conducted 3 and 12 months after quit date. The primary outcome was prolonged, CO-verified abstinence from months 4 to 12 during which time no more than five cigarettes were smoked. The secondary outcomes included self-reported abstinence during the previous 7 days at 3 and 12 months, CO-verified abstinence at 12 months, costs (NHS and NHS and participant medication costs perspectives) and quality-adjusted life-years. Logistic regression analyses were conducted to investigate effect-modifying variables. A simultaneous qualitative process evaluation was conducted to help interpret the trial results. Data from 1404 participants were used for the final analysis, after excluding three participants who died before the 12-month follow-up. The proportion with prolonged abstinence from months 4 to 12 after quit date was 36.9% in the intervention group and 38.6% in the control group. There was no statistically significant difference between the groups (odds ratio 0.93, 95% confidence interval 0.75 to 1.15; p = 0.509). There were no statistically significant differences between the groups in secondary smoking outcomes. People who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. However, there were no differences between the groups in the proportion of participants who reported that they knew any more about coping skills, and no differences in reported use of strategies to cope with urges to smoke between the trial groups. The qualitative study found that some quitters considered self-help booklets unhelpful for smoking relapse prevention, although positive feedback by participants was common. Among quitters who had stopped smoking with the aid of intensive behavioural support, there was no significant difference in the likelihood of smoking relapse between those who subsequently received a set of eight revised Forever Free booklets and those who received a single leaflet. Although many people had suboptimal strategies to prevent relapse and most relapsed, the Forever Free booklets proved an ineffective medium for teaching them the skills to prevent relapse. Further research should focus on interventions that may increase the use of coping skills when required. Current Controlled Trials ISRCTN36980856.

Concealing with structured light.

PubMed

Sun, Jingbo; Zeng, Jinwei; Wang, Xi; Cartwright, Alexander N; Litchinitser, Natalia M

2014-02-13

While making objects less visible (or invisible) to a human eye or a radar has captured people's imagination for centuries, current attempts towards realization of this long-awaited functionality range from various stealth technologies to recently proposed cloaking devices. A majority of proposed approaches share a number of common deficiencies such as design complexity, polarization effects, bandwidth, losses and the physical size or shape requirement complicating their implementation especially at optical frequencies. Here we demonstrate an alternative way to conceal macroscopic objects by structuring light itself. In our approach, the incident light is transformed into an optical vortex with a dark core that can be used to conceal macroscopic objects. Once such a beam passed around the object it is transformed back into its initial Gaussian shape with minimum amplitude and phase distortions. Therefore, we propose to use that dark core of the vortex beam to conceal an object that is macroscopic yet small enough to fit the dark (negligibly low intensity) region of the beam. The proposed concealing approach is polarization independent, easy to fabricate, lossless, operates at wavelengths ranging from 560 to 700 nm, and can be used to hide macroscopic objects providing they are smaller than vortex core.

Cycles of abuse nurtured by concealment: a clinical report.

PubMed

Wijma, Barbro; Thapar-Björkert, Suruchi; Hammarström, Nevija Cah; Swahnberg, Katarina

2007-09-01

At present, health care staff do not seem to have sufficient knowledge about their patients' abusive experiences. The aim of the present study is to analyze and discuss what the implications might be for the encounter between patients and health care professionals, when experiences of abuse are concealed. The methodology of this article is varied: a personal narrative, medical records, sociological theoretical literature and empirical evidence. From the narrative we learn that concealment of abuse was devastating for the patient. She was "treated" in vain as a correct diagnosis was not made, while abuse by her father continued. Health care staff also violated her, which she told her therapist, but her protests were not acknowledged. Ten years of treatment thus made her even more sick. This case story focuses on the mechanisms which nurture concealment of a patient's history of abuse, such as structural and symbolic violence. We also suggest ways to break "cycles of abuse". Help the patient to stop concealing also means that she/he leaves a victim role, gets in charge of the situation and takes a first step towards empowerment. In this way, health care settings can become enabling and empowering environments.

[Cardioversion for paroxysmal supraventricular tachycardia during lung surgery in a patient with concealed Wolff-Parkinson-White syndrome].

PubMed

Sato, Yoshiharu; Nagata, Hirofumi; Inoda, Ayako; Miura, Hiroko; Watanabe, Yoko; Suzuki, Kenji

2014-10-01

We report a case of paroxysmal supraventricular tachycardia (PSVT) that occurred during video-assisted thoracoscopic (VATS) lobectomy in a patient with concealed Wolff-Parkinson-White (WPW) syndrome. A 59-year-old man with lung cancer was scheduled for VATS lobectomy under general anesthesia. After inserting a thoracic epidural catheter, general anesthesia was induced with intravenous administration of propofol. Anesthesia was maintained with inhalation of desfurane in an air/oxygen mixture and intravenous infusion of remifentanil. Recurrent PSVT occurred three times, and the last episode of PSVT continued for 50 minutes regardless of administration of antiarrhythmic drugs. Synchronized electric shock via adhesive electrode pads on the patient's chest successfully converted PSVT back to normal sinus rhythm. The remaining course and postoperative period were uneventful. An electrophysiological study performed after hospital discharge detected concealed WPW syndrome, which had contributed to the development of atrioventricular reciprocating tachycardia. Concealed WPW syndrome is a rare, but critical complication that could possibly cause lethal atrial tachyarrhythmias during the perioperative period. In the present case, cardioversion using adhesive electrode pads briefly terminated PSVT in a patient with concealed WPW syndrome.

Apply network coding for H.264/SVC multicasting

NASA Astrophysics Data System (ADS)

Wang, Hui; Kuo, C.-C. Jay

2008-08-01

In a packet erasure network environment, video streaming benefits from error control in two ways to achieve graceful degradation. The first approach is application-level (or the link-level) forward error-correction (FEC) to provide erasure protection. The second error control approach is error concealment at the decoder end to compensate lost packets. A large amount of research work has been done in the above two areas. More recently, network coding (NC) techniques have been proposed for efficient data multicast over networks. It was shown in our previous work that multicast video streaming benefits from NC for its throughput improvement. An algebraic model is given to analyze the performance in this work. By exploiting the linear combination of video packets along nodes in a network and the SVC video format, the system achieves path diversity automatically and enables efficient video delivery to heterogeneous receivers in packet erasure channels. The application of network coding can protect video packets against the erasure network environment. However, the rank defficiency problem of random linear network coding makes the error concealment inefficiently. It is shown by computer simulation that the proposed NC video multicast scheme enables heterogenous receiving according to their capacity constraints. But it needs special designing to improve the video transmission performance when applying network coding.

On the Upward Bias of the Dissimilarity Index and Its Corrections

ERIC Educational Resources Information Center

Mazza, Angelo; Punzo, Antonio

2015-01-01

The dissimilarity index of Duncan and Duncan is widely used in a broad range of contexts to assess the overall extent of segregation in the allocation of two groups in two or more units. Its sensitivity to random allocation implies an upward bias with respect to the unknown amount of systematic segregation. In this article, following a multinomial…

Dynamic Quantum Allocation and Swap-Time Variability in Time-Sharing Operating Systems.

ERIC Educational Resources Information Center

Bhat, U. Narayan; Nance, Richard E.

The effects of dynamic quantum allocation and swap-time variability on central processing unit (CPU) behavior are investigated using a model that allows both quantum length and swap-time to be state-dependent random variables. Effective CPU utilization is defined to be the proportion of a CPU busy period that is devoted to program processing, i.e.…

Authenticating concealed private data while maintaining concealment

DOEpatents

Thomas, Edward V [Albuquerque, NM; Draelos, Timothy J [Albuquerque, NM

2007-06-26

A method of and system for authenticating concealed and statistically varying multi-dimensional data comprising: acquiring an initial measurement of an item, wherein the initial measurement is subject to measurement error; applying a transformation to the initial measurement to generate reference template data; acquiring a subsequent measurement of an item, wherein the subsequent measurement is subject to measurement error; applying the transformation to the subsequent measurement; and calculating a Euclidean distance metric between the transformed measurements; wherein the calculated Euclidean distance metric is identical to a Euclidean distance metric between the measurement prior to transformation.

Predictive value of ADAMTS-13 on concealed chronic renal failure in COPD patients

PubMed Central

Zeng, Mian; Chen, Qingui; Liang, Wenjie; He, Wanmei; Zheng, Haichong; Huang, Chunrong

2017-01-01

Background Impaired renal function is often neglected in COPD patients. Considering that COPD patients usually have an ongoing prothrombotic state and systemic inflammation status, we investigated the association among them and explored the predictive value of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13), on concealed chronic renal failure (CRF) in COPD patients. Methods COPD patients were recruited from the First Affiliated Hospital of Sun Yat-Sen University between January 2015 and December 2016. Control was selected from contemporaneous hospitalized patients without COPD and matched by age and gender at a ratio of 1:1. Estimated glomerular filtration rate (eGFR) was calculated by using the Chronic Kidney Disease Epidemiology Collaboration formula, and all subjects were categorized as having normal renal function (eGFR ≥60 mL min−1 1.73 m−2) and having concealed CRF (normal serum creatinine while eGFR <60 mL min−1 1.73 m−2). Independent correlates of concealed CRF were investigated by logistic regression analysis, and receiver operating characteristic (ROC) curves were used to determine the predictive value of ADAMTS-13. Results In total, 106 COPD and 106 non-COPD patients were finally recruited, and the incidences of concealed CRF were 19.81% and 7.55%, respectively. ADAMTS-13 (odds ratio [OR] =0.858, 95% CI =0.795–0.926), D-dimer (OR =1.095, 95% CI =1.027–1.169), and C-reactive protein (OR =1.252, 95% CI =1.058–1.480) were significantly associated with concealed CRF. Sensitivity and specificity at an ADAMTS-13 cutoff of 318.72 ng/mL were 100% and 81.2%, respectively. The area under the ROC curve was 0.959. Conclusion Prothrombotic state and systemic inflammation status might contribute to explaining the high incidence of concealed CRF in COPD, and plasma ADAMTS-13 levels may serve as a strong predictor. PMID:29255356

Concealed renal failure and adverse drug reactions in older patients with type 2 diabetes mellitus.

PubMed

Corsonello, Andrea; Pedone, Claudio; Corica, Francesco; Mazzei, Bruno; Di Iorio, Angelo; Carbonin, Pierugo; Incalzi, Raffaele Antonelli

2005-09-01

In elderly patients serum creatinine may be normal despite decreased glomerular filtration rate (GFR). The aim of this study was to evaluate the prevalence of this "concealed" renal failure, i.e., renal failure with normal serum creatinine levels, in elderly diabetic patients, and to verify whether it is a risk factor for adverse drug reactions (ADR) to hydrosoluble drugs. We used data on 2257 hospitalized patients with type 2 diabetes mellitus enrolled in the Gruppo Italiano di Farmacovigilanza nell'Anziano study. On the basis of serum creatinine and calculated GFR, patients were grouped as follows: normal renal function (normal serum creatinine levels and normal GFR), concealed (normal serum creatinine levels and reduced GFR), or overt (increased creatinine levels and reduced GFR) renal failure. GFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation. The outcome of the study was the incidence of ADR to hydrosoluble drugs during the hospital stay. The relationship between renal function and ADR was evaluated using Cox regression analysis including potential confounders. Concealed renal failure was observed in 363 (16.1%) of patients studied. Patients with concealed or overt renal failure were older, had more frequently cognitive impairment and polypharmacy, and had lower serum albumin levels than did those with normal renal function. Both concealed (hazard ratio = 1.90; 95% confidence interval, 1.04-3.48; p =.036) and overt (hazard ratio = 2.23; 95% confidence interval, 1.40-3.55; p =.001) renal failure were significantly associated with ADR to hydrosoluble drugs. The use of more than four drugs also qualified as an independent risk factor for ADRs to hydrosoluble drugs during hospital stay. Older diabetic patients should be systematically screened to ascertain the presence of concealed renal failure in an attempt to optimize the pharmacological treatment and reduce the risk of ADRs.

A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

ERIC Educational Resources Information Center

Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

2017-01-01

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Mentalization-based therapy for parents in entrenched conflict: A random allocation feasibility study.

PubMed

Hertzmann, Leezah; Target, Mary; Hewison, David; Casey, Polly; Fearon, Pasco; Lassri, Dana

2016-12-01

To explore the effectiveness of a mentalization-based therapeutic intervention specifically developed for parents in entrenched conflict over their children. To the best of our knowledge, this is the first randomized controlled intervention study in the United Kingdom to work with both parents postseparation, and the first to focus on mentalization in this situation. Using a mixed-methods study design, 30 parents were randomly allocated to either mentalization-based therapy for parental conflict-Parenting Together, or the Parents' Group, a psycho-educational intervention for separated parents based on elements of the Separated Parents Information Program-part of the U.K. Family Justice System and approximating to treatment as usual. Given the challenges of recruiting parents in these difficult circumstances, the sample size was small and permitted only the detection of large differences between conditions. The data, involving repeated measures of related individuals, was explored statistically, using hierarchical linear modeling, and qualitatively. Significant findings were reported on the main predicted outcomes, with clinically important trends on other measures. Qualitative findings further contributed to the understanding of parents' subjective experience, pre- and posttreatment. Findings indicate that a larger scale randomized controlled trial would be worthwhile. These encouraging findings shed light on the dynamics maintaining these high-conflict situations known to be damaging to children. We established that both forms of intervention were acceptable to most parents, and we were able to operate a random allocation design with extensive quantitative and qualitative assessments of the kind that would make a larger-scale trial feasible and productive. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Psychological and social correlates of HIV status disclosure: the significance of stigma visibility.

PubMed

Stutterheim, Sarah E; Bos, Arjan E R; Pryor, John B; Brands, Ronald; Liebregts, Maartje; Schaalma, Herman P

2011-08-01

HIV-related stigma, psychological distress, self-esteem, and social support were investigated in a sample comprising people who have concealed their HIV status to all but a selected few (limited disclosers), people who could conceal but chose to be open (full disclosers), and people who had visible symptoms that made concealing difficult (visibly stigmatized). The visibly stigmatized and full disclosers reported significantly more stigma experiences than limited disclosers, but only the visibly stigmatized reported more psychological distress, lower self-esteem, and less social support than limited disclosers. This suggests that having a visible stigma is more detrimental than having a concealable stigma. Differences in psychological distress and self-esteem between the visibly stigmatized and full disclosers were mediated by social support while differences between the visibly stigmatized and limited disclosers were mediated by both social support and stigma. These findings suggest that social support buffers psychological distress in people with HIV.

Sexual and gender minority identity disclosure during undergraduate medical education: "in the closet" in medical school.

PubMed

Mansh, Matthew; White, William; Gee-Tong, Lea; Lunn, Mitchell R; Obedin-Maliver, Juno; Stewart, Leslie; Goldsmith, Elizabeth; Brenman, Stephanie; Tran, Eric; Wells, Maggie; Fetterman, David; Garcia, Gabriel

2015-05-01

To assess identity disclosure among sexual and gender minority (SGM) students pursuing undergraduate medical training in the United States and Canada. From 2009 to 2010, a survey was made available to all medical students enrolled in the 176 MD- and DO-granting medical schools in the United States and Canada. Respondents were asked about their sexual and gender identity, whether they were "out" (i.e., had publicly disclosed their identity), and, if they were not, their reasons for concealing their identity. The authors used a mixed-methods approach and analyzed quantitative and qualitative survey data. Of 5,812 completed responses (of 101,473 eligible respondents; response rate 5.7%), 920 (15.8%) students from 152 (of 176; 86.4%) institutions identified as SGMs. Of the 912 sexual minorities, 269 (29.5%) concealed their sexual identity in medical school. Factors associated with sexual identity concealment included sexual minority identity other than lesbian or gay, male gender, East Asian race, and medical school enrollment in the South or Central regions of North America. The most common reasons for concealing one's sexual identity were "nobody's business" (165/269; 61.3%), fear of discrimination in medical school (117/269; 43.5%), and social or cultural norms (110/269; 40.9%). Of the 35 gender minorities, 21 (60.0%) concealed their gender identity, citing fear of discrimination in medical school (9/21; 42.9%) and lack of support (9/21; 42.9%). SGM students continue to conceal their identity during undergraduate medical training. Medical institutions should adopt targeted policies and programs to better support these individuals.

Concealing a shiny facial skin appearance by an Aerogel-based formula. In vitro and in vivo studies.

PubMed

Cassin, G; Diridollou, S; Flament, F; Adam, A S; Pierre, P; Colomb, L; Morancais, J L; Qiu, H

2018-02-01

To explore, in vitro and in vivo, the potential interest of an Aerogel-based formula, in concealing a naturally shiny facial skin. In vitro, various formulae and ingredients were applied as a thin film onto contrast plates and studied through measuring the shine induced following pump spraying of a mixture of oleic acid and mineral water as a sebum/sweat mix model. In such a test, an Aerogel ingredient led to very positive results. In vivo, two different formulae with various concentrations of Aerogel were randomly tested on half side of the face vs. bare side of Chinese women, under some provocative environmental conditions, known to enhance facial shine. These conditions comprised a normal activity under a hot and highly humid summer time followed - or not - by a hamam session. Both studies included comparative evaluations using a half-face procedure (treated/untreated or vehicle). In the first case, evaluations were quantitatively carried out, whereas the second one was based on a quantitative self-evaluations from standardized full-face photographs RESULTS: In vitro, the tested Aerogel, incorporated at 1% or 2% concentration in a common O/W cosmetic emulsion, shows an immediate light scattering effect, thereby masking shine. Such effect appears of much higher amplitude than that of two other tested particulate ingredients (Talc and Perlite). A noticeable remanence of anti-shine effect was confirmed in vivo in extreme conditions. The latter was self-perceived by all participants in the second study. This result is likely related to the super hydrophobic behaviour of the Aerogel. As cosmetic ingredient, this new Aerogel appears as a highly promising ingredient for concealing the facial skin shine, a source of complaint from many consumers living in hot and humid regions. © 2017 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Microwave Technique for Detecting and Locating Concealed Weapons

DOT National Transportation Integrated Search

1971-12-01

The subject of this report is the evaluation of a microwave technique for detecting and locating weapons concealed under clothing. The principal features of this technique are: persons subjected to search are not exposed to 'objectional' microwave ra...

Age-Related Changes in Temporal Allocation of Visual Attention: Evidence from the Rapid Serial Visual Presentation (RSVP) Paradigm

ERIC Educational Resources Information Center

Berger, Carole; Valdois, Sylviane; Lallier, Marie; Donnadieu, Sophie

2015-01-01

The present study explored the temporal allocation of attention in groups of 8-year-old children, 10-year-old children, and adults performing a rapid serial visual presentation task. In a dual-condition task, participants had to detect a briefly presented target (T2) after identifying an initial target (T1) embedded in a random series of…

The Quantitative Effect of Students Using Podcasts in a First Year Undergraduate Exercise Physiology Module

ERIC Educational Resources Information Center

Abt, Grant; Barry, Tim

2007-01-01

This study reports the quantitative effect of students using podcasts in a 1st year undergraduate exercise physiology module. From a cohort of 70 students, 50 volunteered and completed the study. Using a pre-post random allocation research design, students were allocated to either a podcast group (PG) or control group (CG) based on a 32-question…

Enhancements and Algorithms for Avionic Information Processing System Design Methodology.

DTIC Science & Technology

1982-06-16

programming algorithm is enhanced by incorporating task precedence constraints and hardware failures. Stochastic network methods are used to analyze...allocations in the presence of random fluctuations. Graph theoretic methods are used to analyze hardware designs, and new designs are constructed with...There, spatial dynamic programming (SDP) was used to solve a static, deterministic software allocation problem. Under the current contract the SDP

Randomised clinical trial of strategies for improving medication compliance in primary hypertension.

PubMed

Sackett, D L; Haynes, R B; Gibson, E S; Hackett, B C; Taylor, D W; Roberts, R S; Johnson, A L

1975-05-31

230 Canadian steelworkers with hypertension took part in a randomised trial to see if compliance with antihypertensive drug regimens could be improved. For care and follow-up these men were randomly allocated to see either their own family doctors outside working-hours or industrial physicians during work shifts; the same men were randomly allocated to receive or not receive an educational programme aimed at instructing them about hypertension and its treatment. Surprisingly, the convenience of follow-up at work had no effect upon these men's compliance with antihypertensive drug regimens. Similarly, although men receiving health education learned a lot about hypertension, they were not more likely to take their medicine.

Quasi-experimental study designs series-paper 1: introduction: two historical lineages.

PubMed

Bärnighausen, Till; Røttingen, John-Arne; Rockers, Peter; Shemilt, Ian; Tugwell, Peter

2017-09-01

The objective of this study was to contrast the historical development of experiments and quasi-experiments and provide the motivation for a journal series on quasi-experimental designs in health research. A short historical narrative, with concrete examples, and arguments based on an understanding of the practice of health research and evidence synthesis. Health research has played a key role in developing today's gold standard for causal inference-the randomized controlled multiply blinded trial. Historically, allocation approaches developed from convenience and purposive allocation to alternate and, finally, to random allocation. This development was motivated both by concerns for manipulation in allocation as well as statistical and theoretical developments demonstrating the power of randomization in creating counterfactuals for causal inference. In contrast to the sequential development of experiments, quasi-experiments originated at very different points in time, from very different scientific perspectives, and with frequent and long interruptions in their methodological development. Health researchers have only recently started to recognize the value of quasi-experiments for generating novel insights on causal relationships. While quasi-experiments are unlikely to replace experiments in generating the efficacy and safety evidence required for clinical guidelines and regulatory approval of medical technologies, quasi-experiments can play an important role in establishing the effectiveness of health care practice, programs, and policies. The papers in this series describe and discuss a range of important issues in utilizing quasi-experimental designs for primary research and quasi-experimental results for evidence synthesis. Copyright © 2017 Elsevier Inc. All rights reserved.

The use of far infra-red radiation for the detection of concealed metal objects

DOT National Transportation Integrated Search

1971-11-01

The use of infrared radiation for the detection of concealed metal objects has been investigated both theoretically and experimentally. The investigation was divided into two phases, one which considered passive techniques, and another which involved...

The use of far infra-red radiation for the detection of concealed metal objects.

DOT National Transportation Integrated Search

1971-11-01

Abstract The use of infrared radiation for the detection : of concealed metal objects has been investigated both : theoretically and experimentally. The investigation was : divided into two phases, one which considered passive : techniques, and anoth...

20 CFR 404.502 - Overpayments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... representative payee for payments made after the beneficiary's death. We will not recover such overpayments from... intentional false statement or representation, or willful concealment of, or deliberate failure to furnish... individual's intentional false statement or representation, or willful concealment of, or deliberate failure...

Management of concealed penis with modified penoplasty.

PubMed

Xu, Jian-Guo; Lv, Chuan; Wang, Yu-Chong; Zhu, Ji; Xue, Chun-Yu

2015-03-01

To investigate the effect of penile degloving in combination with penoscrotal angle reconstruction for the correction of concealed penis. A foreskin circumcision incision was made along the coronal sulcus. After a sharp dissection under the superficial layer of tunica albuginea, the penile shaft was degloved to release the fibrous bands of the tunica dartos. Through a longitudinal incision or Z-plasty at the penoscrotal junction, securing of the tunica albuginea to the proximal tunica dartos was performed. The penoscrotal angle was reconstructed. This procedure effectively corrected the concealed penis, while correcting other problems such as phimosis. From August 2008 to August 2013, we performed 41 procedures for concealed penis. Correction was successful in all patients with an improved median length of 2.1 cm in the flaccid state. Follow-up ranged from 6 months to 2 years, and satisfactory cosmetic outcomes were obtained without scars or erectile discomfort. Our technique includes degloving and penoscrotal angle reconstruction, which provides proper visualization for fixation of the penile base. The longitudinal or Z-plasty incision also opened the degloving dead cavity, which was good for drainage. The procedure is straight forward with good functional and cosmetic outcomes and is thus ideal for correction of the concealed penis. Copyright © 2015 Elsevier Inc. All rights reserved.

Modified penoplasty for concealed penis in children.

PubMed

Yang, Tianyou; Zhang, Liyu; Su, Cheng; Li, Zhongmin; Wen, Yingquan

2013-09-01

To report a modified penoplasty technique for concealed penis in children. Between January 2006 and June 2012, 201 cases of concealed penis were surgically repaired with modified penoplasty. The modified penoplasty technique consisted of 3 major steps: (1) degloved the penile skin and excised the inner prepuce, (2) advanced penoscrotal skin to cover penile shaft, and (3) fixed the penis base and reconstructed the penoscrotal angle. Two hundred one cases of concealed penis were enrolled in this study over a period of 6 years. Mean age at the time of surgery was 5.3 years (range 1-13 years) and mean operative time was 40 minutes (range 30-65minutes). All patients were routinely followed up at 1, 3, and 6 months after surgery. Most patients developed postoperative edema and were resolved within 1 month, whereas 20 cases developed prolonged postoperative edema, especially at the site of frenulum, which took 3 months to be resolved. Ten cases had retraction after surgery. No erection difficulties were recorded. Patients/parents reported better hygiene and improved visualization and accessibility of penis after surgery and were satisfied with the cosmetic outcome. The result of this study shows that the modified penoplasty technique is a simple, safe, and effective procedure for concealed penis with satisfied cosmetic outcome. Copyright © 2013 Elsevier Inc. All rights reserved.

Hiding and finding: the relationship between visual concealment and visual search.

PubMed

Smilek, Daniel; Weinheimer, Laura; Kwan, Donna; Reynolds, Mike; Kingstone, Alan

2009-11-01

As an initial step toward developing a theory of visual concealment, we assessed whether people would use factors known to influence visual search difficulty when the degree of concealment of objects among distractors was varied. In Experiment 1, participants arranged search objects (shapes, emotional faces, and graphemes) to create displays in which the targets were in plain sight but were either easy or hard to find. Analyses of easy and hard displays created during Experiment 1 revealed that the participants reliably used factors known to influence search difficulty (e.g., eccentricity, target-distractor similarity, presence/absence of a feature) to vary the difficulty of search across displays. In Experiment 2, a new participant group searched for the targets in the displays created by the participants in Experiment 1. Results indicated that search was more difficult in the hard than in the easy condition. In Experiments 3 and 4, participants used presence versus absence of a feature to vary search difficulty with several novel stimulus sets. Taken together, the results reveal a close link between the factors that govern concealment and the factors known to influence search difficulty, suggesting that a visual search theory can be extended to form the basis of a theory of visual concealment.

Prospective effects of social support on internalized homonegativity and sexual identity concealment among middle-aged and older gay men: a longitudinal cohort study.

PubMed

Lyons, Anthony; Pepping, Christopher A

2017-09-01

Middle-aged and older gay men experience higher rates of depression and anxiety compared to their heterosexual counterparts, with internalized homonegativity and sexual identity concealment known to be major stress-related contributors. This study examined the prospective effect of different types and sources of social support on internalized homonegativity and sexual identity concealment experienced among middle-aged and older gay men. A longitudinal survey involving two waves of data collection separated by 12 months was conducted among a cohort of 186 gay-identified men aged 40 years and older. Two types of social support were found to be important. Greater baseline tangible or practical support independently predicted lower internalized homonegativity at 12-month follow-up, while greater baseline emotional or psychological support independently predicted a lower tendency toward sexual identity concealment at 12-month follow-up. Greater baseline support from community or government agencies, such as health services and support organizations, predicted higher internalized homonegativity at 12-month follow-up. These findings suggest that tangible and emotional support may be beneficial in reducing internalized homonegativity and sexual identity concealment among middle-aged and older gay men. Ensuring that services provide environments that do not compound the stressful impact of stigma also appears to be important.

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Examining the Minimal Required Elements of a Computer-Tailored Intervention Aimed at Dietary Fat Reduction: Results of a Randomized Controlled Dismantling Study

ERIC Educational Resources Information Center

Kroeze, Willemieke; Oenema, Anke; Dagnelie, Pieter C.; Brug, Johannes

2008-01-01

This study investigated the minimally required feedback elements of a computer-tailored dietary fat reduction intervention to be effective in improving fat intake. In all 588 Healthy Dutch adults were randomly allocated to one of four conditions in an randomized controlled trial: (i) feedback on dietary fat intake [personal feedback (P feedback)],…

Random Measurement Error as a Source of Discrepancies between the Reports of Wives and Husbands Concerning Marital Power and Task Allocation.

ERIC Educational Resources Information Center

Quarm, Daisy

1981-01-01

Findings for couples (N=119) show wife's work, money, and spare time low between-spouse correlations are due in part to random measurement error. Suggests that increasing reliability of measures by creating multi-item indices can also increase correlations. Car purchase, vacation, and child discipline were not accounted for by random measurement…

A Dexterous Optional Randomized Response Model

ERIC Educational Resources Information Center

Tarray, Tanveer A.; Singh, Housila P.; Yan, Zaizai

2017-01-01

This article addresses the problem of estimating the proportion Pi[subscript S] of the population belonging to a sensitive group using optional randomized response technique in stratified sampling based on Mangat model that has proportional and Neyman allocation and larger gain in efficiency. Numerically, it is found that the suggested model is…

The use of far infra-red radiation for the detection of concealed metal objects.

DOT National Transportation Integrated Search

1971-11-01

The use of infra-red radiation for the detection : of conceal ed metal objects has been investiga ted both : theoretically and experimentally. The investigation was : divided into two phases, one which considered passive : techniques, and another whi...

The study design elements employed by researchers in preclinical animal experiments from two research domains and implications for automation of systematic reviews.

PubMed

O'Connor, Annette M; Totton, Sarah C; Cullen, Jonah N; Ramezani, Mahmood; Kalivarapu, Vijay; Yuan, Chaohui; Gilbert, Stephen B

2018-01-01

Systematic reviews are increasingly using data from preclinical animal experiments in evidence networks. Further, there are ever-increasing efforts to automate aspects of the systematic review process. When assessing systematic bias and unit-of-analysis errors in preclinical experiments, it is critical to understand the study design elements employed by investigators. Such information can also inform prioritization of automation efforts that allow the identification of the most common issues. The aim of this study was to identify the design elements used by investigators in preclinical research in order to inform unique aspects of assessment of bias and error in preclinical research. Using 100 preclinical experiments each related to brain trauma and toxicology, we assessed design elements described by the investigators. We evaluated Methods and Materials sections of reports for descriptions of the following design elements: 1) use of comparison group, 2) unit of allocation of the interventions to study units, 3) arrangement of factors, 4) method of factor allocation to study units, 5) concealment of the factors during allocation and outcome assessment, 6) independence of study units, and 7) nature of factors. Many investigators reported using design elements that suggested the potential for unit-of-analysis errors, i.e., descriptions of repeated measurements of the outcome (94/200) and descriptions of potential for pseudo-replication (99/200). Use of complex factor arrangements was common, with 112 experiments using some form of factorial design (complete, incomplete or split-plot-like). In the toxicology dataset, 20 of the 100 experiments appeared to use a split-plot-like design, although no investigators used this term. The common use of repeated measures and factorial designs means understanding bias and error in preclinical experimental design might require greater expertise than simple parallel designs. Similarly, use of complex factor arrangements creates novel challenges for accurate automation of data extraction and bias and error assessment in preclinical experiments.

'I am doing fine only because I have not told anyone': the necessity of concealment in the lives of people living with HIV in India.

PubMed

George, Mathew Sunil; Lambert, Helen

2015-01-01

In HIV prevention and care programmes, disclosure of status by HIV-positive individuals is generally encouraged to contain the infection and provide adequate support to the person concerned. Lack of disclosure is generally framed as a barrier to preventive behaviours and accessing support. The assumption that disclosure is beneficial is also reflected in studies that aim to identify determinants of disclosure and recommend individual-level measures to promote disclosure. However, in contexts where HIV infection is stigmatised and there is fear of rejection and discrimination among those living with HIV, concealment of status becomes a way to try and regain as much as possible the life that was disrupted by the discovery of HIV infection. In this study of HIV-positive women and children in India, concealment was considered essential by individuals and families of those living with HIV to re-establish and maintain their normal lives in an environment where stigma and discrimination were prevalent. This paper describes why women and care givers of children felt the need to conceal HIV status, the various ways in which people tried to do so and the implications for treatment of people living with HIV. We found that while women were generally willing to disclose their status to their husband or partner, they were very keen to conceal their status from all others, including family members. Parents and carers with an HIV-positive child were not willing to disclose this status to the child or to others. Understanding the different rationales for concealment would help policy makers and programme managers to develop more appropriate care management strategies and train care providers to assist clients in accessing care and support without disrupting their lives.

‘I am doing fine only because I have not told anyone’: the necessity of concealment in the lives of people living with HIV in India

PubMed Central

George, Mathew Sunil; Lambert, Helen

2015-01-01

In HIV prevention and care programmes, disclosure of status by HIV-positive individuals is generally encouraged to contain the infection and provide adequate support to the person concerned. Lack of disclosure is generally framed as a barrier to preventive behaviours and accessing support. The assumption that disclosure is beneficial is also reflected in studies that aim to identify determinants of disclosure and recommend individual-level measures to promote disclosure. However, in contexts where HIV infection is stigmatised and there is fear of rejection and discrimination among those living with HIV, concealment of status becomes a way to try and regain as much as possible the life that was disrupted by the discovery of HIV infection. In this study of HIV-positive women and children in India, concealment was considered essential by individuals and families of those living with HIV to re-establish and maintain their normal lives in an environment where stigma and discrimination were prevalent. This paper describes why women and care givers of children felt the need to conceal HIV status, the various ways in which people tried to do so and the implications for treatment of people living with HIV. We found that while women were generally willing to disclose their status to their husband or partner, they were very keen to conceal their status from all others, including family members. Parents and carers with an HIV-positive child were not willing to disclose this status to the child or to others. Understanding the different rationales for concealment would help policy makers and programme managers to develop more appropriate care management strategies and train care providers to assist clients in accessing care and support without disrupting their lives. PMID:25706959

Injury reporting rates and injury concealment patterns differ between high-school cirque performers and basketball players.

PubMed

Long, Ashley S; Ambegaonkar, Jatin P; Fahringer, Patty M

2011-12-01

The performing arts style of cirque has grown in popularity, with high-school participants increasingly practicing this style. Still, little research has examined the injury reporting rates and patterns in this population. Our study aimed to compare injury reporting rates and injury concealment patterns between high-school cirque performers and a peer-group of basketball players. Fifty participants (30 cirque, 20 basketball) completed a 12-item injury history and concealment instrument with chi-squared analyses and Fisher's exact tests comparing groups (p = 0.05). While no group differences (p = 0.36) existed in injuries reported, basketball players were more likely (p = 0.01) to miss participation due to injury than cirque performers. No significant difference existed between participants regarding which healthcare provider they reported to first (p = 0.27), but basketball players reported their injuries to the athletic trainer at higher rates (50%) than cirque performers (20%). A nonsignificant trend (p = 0.08) was noted in promptness to report injury, with more cirque performers (13%) concealing their injuries than basketball players (5%). Several reasons were noted for concealment of injury, with the most common being the belief that the injury would "go away" on its own. Knee injuries were most common in basketball players (23.7%) and back and knee injuries (10.5% each) in cirque performers. Despite similar injury rates, cirque participants concealed injuries more than peer-basketball players. Reasons may include losing performance roles, unfamiliarity and low trust with healthcare providers, ignorance about initially minor-looking injuries, and higher pain tolerance thresholds. Education and communication are essential to allow performing artists to seek healthcare support. Research is needed to appropriately understand and meet the needs of this underserved performing artist population.

Dynamic fair node spectrum allocation for ad hoc networks using random matrices

NASA Astrophysics Data System (ADS)

Rahmes, Mark; Lemieux, George; Chester, Dave; Sonnenberg, Jerry

2015-05-01

Dynamic Spectrum Access (DSA) is widely seen as a solution to the problem of limited spectrum, because of its ability to adapt the operating frequency of a radio. Mobile Ad Hoc Networks (MANETs) can extend high-capacity mobile communications over large areas where fixed and tethered-mobile systems are not available. In one use case with high potential impact, cognitive radio employs spectrum sensing to facilitate the identification of allocated frequencies not currently accessed by their primary users. Primary users own the rights to radiate at a specific frequency and geographic location, while secondary users opportunistically attempt to radiate at a specific frequency when the primary user is not using it. We populate a spatial radio environment map (REM) database with known information that can be leveraged in an ad hoc network to facilitate fair path use of the DSA-discovered links. Utilization of high-resolution geospatial data layers in RF propagation analysis is directly applicable. Random matrix theory (RMT) is useful in simulating network layer usage in nodes by a Wishart adjacency matrix. We use the Dijkstra algorithm for discovering ad hoc network node connection patterns. We present a method for analysts to dynamically allocate node-node path and link resources using fair division. User allocation of limited resources as a function of time must be dynamic and based on system fairness policies. The context of fair means that first available request for an asset is not envied as long as it is not yet allocated or tasked in order to prevent cycling of the system. This solution may also save money by offering a Pareto efficient repeatable process. We use a water fill queue algorithm to include Shapley value marginal contributions for allocation.

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.

PubMed

Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki S; Ismail, Hussain Imam H J Muhammad; Chotpitayasunondh, Tawee; Chua, Mary Noreen; Luong, Chan Quang; Rusmil, Kusnandi; Wirawan, Dewa Nyoman; Nallusamy, Revathy; Pitisuttithum, Punnee; Thisyakorn, Usa; Yoon, In-Kyu; van der Vliet, Diane; Langevin, Edith; Laot, Thelma; Hutagalung, Yanee; Frago, Carina; Boaz, Mark; Wartel, T Anh; Tornieporth, Nadia G; Saville, Melanie; Bouckenooghe, Alain

2014-10-11

An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children. We did an observer-masked, randomised controlled, multicentre, phase 3 trial in five countries in the Asia-Pacific region. Between June 3, and Dec 1, 2011, healthy children aged 2-14 years were randomly assigned (2:1), by computer-generated permuted blocks of six with an interactive voice or web response system, to receive three injections of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV), or placebo, at months 0, 6, and 12. Randomisation was stratified by age and site. Participants were followed up until month 25. Trial staff responsible for the preparation and administration of injections were unmasked to group allocation, but were not included in the follow-up of the participants; allocation was concealed from the study sponsor, investigators, and parents and guardians. Our primary objective was to assess protective efficacy against symptomatic, virologically confirmed dengue, irrespective of disease severity or serotype, that took place more than 28 days after the third injection. The primary endpoint was for the lower bound of the 95% CI of vaccine efficacy to be greater than 25%. Analysis was by intention to treat and per procotol. This trial is registered with ClinicalTrials.gov, number NCT01373281. We randomly assigned 10,275 children to receive either vaccine (n=6851) or placebo (n=3424), of whom 6710 (98%) and 3350 (98%), respectively, were included in the primary analysis. 250 cases of virologically confirmed dengue took place more than 28 days after the third injection (117 [47%] in the vaccine group and 133 [53%] in the control group). The primary endpoint was achieved with 56·5% (95% CI 43·8-66·4) efficacy. We recorded 647 serious adverse events (402 [62%] in the vaccine group and 245 [38%] in the control group). 54 (1%) children in the vaccine group and 33 (1%) of those in the control group had serious adverse events that happened within 28 days of vaccination. Serious adverse events were consistent with medical disorders in this age group and were mainly infections and injuries. Our findings show that dengue vaccine is efficacious when given as three injections at months 0, 6, and 12 to children aged 2-14 years in endemic areas in Asia, and has a good safety profile. Vaccination could reduce the incidence of symptomatic infection and hospital admission and has the potential to provide an important public health benefit. Sanofi Pasteur. Copyright © 2014 Elsevier Ltd. All rights reserved.

Geophysical and geochemical data from the area of the Pebble Cu-Au-Mo porphyry deposit, southwestern Alaska: Contributions to assessment techniques for concealed mineral resources

USGS Publications Warehouse

Anderson, E.D.; Smith, S.M.; Giles, S.A.; Granitto, Matthew; Eppinger, R.G.; Bedrosian, P.A.; Shah, A.K.; Kelley, K.D.; Fey, D.L.; Minsley, B.J.; Brown, P.J.

2011-01-01

In 2007, the U.S. Geological Survey began a multidisciplinary study in southwest Alaska to investigate the setting and detectability of mineral deposits in concealed volcanic and glacial terranes. The study area hosts the world-class Pebble porphyry Cu-Au-Mo deposit, and through collaboration with the Pebble Limited Partnership, a range of geophysical and geochemical investigations was carried out in proximity to the deposit. The deposit is almost entirely concealed by tundra, glacial deposits, and post-mineralization volcanic rocks. The discovery of mineral resources beneath cover is becoming more important because most of the mineral resources at the surface have already been discovered. Research is needed to identify ways in which to assess for concealed mineral resources. This report presents the uninterpreted geophysical measurements and geochemical and mineralogical analytical data from samples collected during the summer field seasons from 2007 to 2010, and makes the data available in a single Geographic Information System (GIS) database.

The inconspicuous penis in children.

PubMed

Cimador, Marcello; Catalano, Pieralba; Ortolano, Rita; Giuffrè, Mario

2015-04-01

The term 'inconspicuous penis' refers to a group of anatomical abnormalities in which the penis looks smaller than is expected. Micropenis can be defined as 'true micropenis'--which results from a defect in the hypothalamic-pituitary-gonadal axis--and 'micropenis secondary to congenital anatomical anomalies of the surrounding and overlying structures'--also known as 'concealed penis'. The different forms of concealed penis include webbed penis, congenital megaprepuce and partially hidden penis caused by prepubic adiposity. This disorder can also have iatrogenic causes resulting from adhesions that are secondary to circumcision--this type of concealed penis is known as 'trapped penis'. However, in both groups, micropenis is defined as a stretched penile length that is at least 2.5 SD below the mean for the patient's age, but without any other penile defects. Patients with true micropenis can be managed with testosterone, which has demonstrated good penile elongation results in the long term. Surgery also has a pivotal role in reconstruction for elongating the penis and for correction of anatomical abnormalities in concealed penis.

A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

PubMed Central

2011-01-01

Background Swine origin influenza A/H1N1 infection (H1N1) emerged in early 2009 and rapidly spread to humans. For most infected individuals, symptoms were mild and self-limited; however, a small number developed a more severe clinical syndrome characterized by profound respiratory failure with hospital mortality ranging from 10 to 30%. While supportive care and neuraminidase inhibitors are the main treatment for influenza, data from observational and interventional studies suggest that the course of influenza can be favorably influenced by agents not classically considered as influenza treatments. Multiple observational studies have suggested that HMGCoA reductase inhibitors (statins) can exert a class effect in attenuating inflammation. The Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial sought to investigate the feasibility of conducting a trial during a global pandemic in critically ill patients with H1N1 with the goal of informing the design of a larger trial powered to determine impact of statins on important outcomes. Methods/Design A multi-national, pilot randomized controlled trial (RCT) of once daily enteral rosuvastatin versus matched placebo administered for 14 days for the treatment of critically ill patients with suspected, probable or confirmed H1N1 infection. We propose to randomize 80 critically ill adults with a moderate to high index of suspicion for H1N1 infection who require mechanical ventilation and have received antiviral therapy for ≤ 72 hours. Site investigators, research coordinators and clinical pharmacists will be blinded to treatment assignment. Only research pharmacy staff will be aware of treatment assignment. We propose several approaches to informed consent including a priori consent from the substitute decision maker (SDM), waived and deferred consent. The primary outcome of the CHAT trial is the proportion of eligible patients enrolled in the study. Secondary outcomes will evaluate adherence to medication administration regimens, the proportion of primary and secondary endpoints collected, the number of patients receiving open-label statins, consent withdrawals and the effect of approved consent models on recruitment rates. Discussion Several aspects of study design including the need to include central randomization, preserve allocation concealment, ensure study blinding compare to a matched placebo and the use novel consent models pose challenges to investigators conducting pandemic research. Moreover, study implementation requires that trial design be pragmatic and initiated in a short time period amidst uncertainty regarding the scope and duration of the pandemic. Trial Registration Number ISRCTN45190901 PMID:21388549

Sensitivity and specificity of CT scanning for determining the number of internally concealed packages in 'body-packers'.

PubMed

Asha, Stephen Edward; Higham, Matthew; Child, Peter

2015-05-01

If package counts on abdominal CTs of body-packers were known to be accurate, follow-up CTs could be avoided. The objective was to determine the accuracy of CT for the number of concealed packages in body-packers, and the reliability of package counts reported by body-packers who admit to concealing drugs. Suspected body-packers were identified from the emergency departments (ED) database. The medical record and radiology reports were reviewed for package counts determined by CT, patient-reported and physically retrieved. The last method was used as the reference standard. Sensitivity, specificity, positive predictive values (PPV) and negative predictive values (NPV) were calculated for CT package count accuracy. Reliability of patient-reported package counts was assessed using Pearson's correlation coefficient. There were 50 confirmed body-packers on whom 104 CT scans were performed. Data for the index and reference tests were available for 84 scans. The sensitivity, specificity, PPV and NPV for CT package count were 63% (95% CI 46% to 77%), 82% (95% CI 67% to 92%), 76% (95% CI 58% to 89%) and 71% (95% CI 56% to 83%) respectively. For CTs with a package count<15, the sensitivity, specificity, PPV and NPV for CT package count were 96% (95% CI 80% to 99%), 95% (95% CI 82% to 99%), 93% (95% CI 76% to 99%) and 97% (95% CI 86% to 100%), respectively. Correlation between patient-reported package counts and the number of packages retrieved was high (r=0.90, p<0.001, R2=81%). The accuracy of CT for determining the number of concealed packages is poor, although when applied to patients with few concealed packages accuracy is high and is useful as a rule-out test. Among patients who have admitted to drug concealment, the number of packages reported to be concealed is reliable. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Drugs for preventing malaria in pregnant women.

PubMed

Garner, P; Gülmezoglu, A M

2006-10-18

Malaria contributes to maternal illness and anaemia in pregnancy, especially in first-time mothers, and can harm the mother and the baby. Drugs given routinely to prevent or mitigate the effects of malaria during pregnancy are often recommended. To assess drugs given to prevent malaria infection and its consequences in pregnant women living in malarial areas. This includes prophylaxis and intermittent preventive treatment (IPT). We searched the Cochrane Infectious Diseases Group Specialized Register (March 2006), CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to March 2006), EMBASE (1974 to March 2006), LILACS (1982 to March 2006), and reference lists. We also contacted researchers working in the field. Randomized and quasi-randomized controlled trials comparing antimalarial drugs given regularly with no antimalarial drugs for preventing malaria in pregnant women living in malaria-endemic areas. Both authors extracted data and assessed methodological quality. Dichotomous variables were combined using relative risks (RR) and weighted mean differences (WMD) for mean values, both with 95% confidence intervals (CI). Sixteen trials (12,638 participants) met the inclusion criteria; two used adequate methods to conceal allocation. Antimalarials reduced antenatal parasitaemia when given to all pregnant women (RR 0.53, 95% CI 0.33 to 0.86; 328 participants, 2 trials), placental malaria (RR 0.34, 95% CI 0.26 to 0.45; 1236 participants, 3 trials), but no effect was detected with perinatal deaths (2890 participants, 4 trials). In women in their first or second pregnancy, antimalarial drugs reduced severe antenatal anaemia (RR 0.62, 95% CI 0.50 to 0.78; 2809 participants, 1 prophylaxis and 2 IPT trials), antenatal parasitaemia (RR 0.27, 95% CI 0.17 to 0.44, random-effects model; 2906 participants, 6 trials), and perinatal deaths (RR 0.73, 95% CI 0.53 to 0.99; 1986 participants, 2 prophylaxis and 1 IPT trial; mean birthweight was higher (WMD 126.70 g, 95% CI 88.64 to 164.75 g; 2648 participants, 8 trials), and low birthweight less frequent (RR 0.57, 95% CI 0.46 to 0.72; 2350 participants, 6 trials). Proguanil performed better than chloroquine in one trial of women of all parities in relation to maternal fever episodes. Sulfadoxine-pyrimethamine performed better than chloroquine in two trials of low-parity women. Chemoprophylaxis or IPT reduces antenatal parasite prevalence and placental malaria when given to women in all parity groups. They also have positive effects on birthweight and possibly on perinatal death in low-parity women.

Chinese herbal medicines for hypercholesterolemia

PubMed Central

Liu, Zhao Lan; Liu, Jian Ping; Zhang, Anthony Lin; Wu, Qiong; Ruan, Yao; Lewith, George; Visconte, Denise

2011-01-01

Background Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents. Objectives To assess the effects of Chinese herbal medicines on hypercholesterolemia. Search strategy We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010). Selection criteria We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. Data collection and analysis Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. Main results We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 ± 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) −0.90 mmol/L, 95% confidence interval (CI) −1.13 to −0.68) . Authors’ conclusions Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials. PMID:21735427

The effect of technology-based interventions on pain, depression, and quality of life in patients with cancer: a systematic review of randomized controlled trials.

PubMed

Agboola, Stephen O; Ju, Woong; Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

2015-03-13

The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients' health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness.

The Effect of Technology-Based Interventions on Pain, Depression, and Quality of Life in Patients With Cancer: A Systematic Review of Randomized Controlled Trials

PubMed Central

Elfiky, Aymen; Kvedar, Joseph C; Jethwani, Kamal

2015-01-01

Background The burden of cancer is increasing; projections over the next 2 decades suggest that the annual cases of cancer will rise from 14 million in 2012 to 22 million. However, cancer patients in the 21st century are living longer due to the availability of novel therapeutic regimens, which has prompted a growing focus on maintaining patients’ health-related quality of life. Telehealth is increasingly being used to connect with patients outside of traditional clinical settings, and early work has shown its importance in improving quality of life and other clinical outcomes in cancer care. Objective The aim of this study was to systematically assess the literature for the effect of supportive telehealth interventions on pain, depression, and quality of life in cancer patients via a systematic review of clinical trials. Methods We searched PubMed, EMBASE, Google Scholar, CINAHL, and PsycINFO in July 2013 and updated the literature search again in January 2015 for prospective randomized trials evaluating the effect of telehealth interventions in cancer care with pain, depression, and quality of life as main outcomes. Two of the authors independently reviewed and extracted data from eligible randomized controlled trials, based on pre-determined selection criteria. Methodological quality of studies was assessed by the Cochrane Collaboration risk of bias tool. Results Of the 4929 articles retrieved from databases and relevant bibliographies, a total of 20 RCTs were included in the final review. The studies were largely heterogeneous in the type and duration of the intervention as well as in outcome assessments. A majority of the studies were telephone-based interventions that remotely connected patients with their health care provider or health coach. The intervention times ranged from 1 week to 12 months. In general, most of the studies had low risk of bias across the domains of the Cochrane Collaboration risk of bias tool, but most of the studies had insufficient information about the allocation concealment domain. Two of the three studies focused on pain control reported significant effects of the intervention; four of the nine studies focus on depression reported significant effects, while only the studies that were focused on quality of life reported significant effects. Conclusions This systematic review demonstrates the potential of telehealth interventions in improving outcomes in cancer care. However, more high-quality large-sized trials are needed to demonstrate cogent evidence of its effectiveness. PMID:25793945

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

The "double life" of bulimia: patients' experiences in daily life interactions.

PubMed

Pettersen, Gunn; Rosenvinge, Jan H; Ytterhus, Borgunn

2008-01-01

This qualitative study, using interviews with 38 subjects, explored how and why they conceal bulimic symptoms and the understanding of concealing in terms of social interaction. A "double life" was described as a dichotomy between being active and outgoing versus performing shameful bulimic behaviors and constantly living with fear of stigmatization, and striving against exposure. Concealing was well planned to avoid such fear, and to preserve dignity. Bulimia may be understood as volitional exertion of interaction control, not just as a result of poor impulse regulation. Understanding the meaning of secrecy and "double life" may facilitate help seeking behavior and guide treatment.

Audio-magnetotelluric survey to characterize the Sunnyside porphyry copper system in the Patagonia Mountains, Arizona

USGS Publications Warehouse

Sampson, Jay A.; Rodriguez, Brian D.

2010-01-01

The Sunnyside porphyry copper system is part of the concealed San Rafael Valley porphyry system located in the Patagonia Mountains of Arizona. The U.S. Geological Survey is conducting a series of multidisciplinary studies as part of the Assessment Techniques for Concealed Mineral Resources project. To help characterize the size, resistivity, and skin depth of the polarizable mineral deposit concealed beneath thick overburden, a regional east-west audio-magnetotelluric sounding profile was acquired. The purpose of this report is to release the audio-magnetotelluric sounding data collected along that east-west profile. No interpretation of the data is included.

Detection and identification of concealed weapons using matrix pencil

NASA Astrophysics Data System (ADS)

Adve, Raviraj S.; Thayaparan, Thayananthan

2011-06-01

The detection and identification of concealed weapons is an extremely hard problem due to the weak signature of the target buried within the much stronger signal from the human body. This paper furthers the automatic detection and identification of concealed weapons by proposing the use of an effective approach to obtain the resonant frequencies in a measurement. The technique, based on Matrix Pencil, a scheme for model based parameter estimation also provides amplitude information, hence providing a level of confidence in the results. Of specific interest is the fact that Matrix Pencil is based on a singular value decomposition, making the scheme robust against noise.

A Randomized Controlled Trial of Exposure Therapy and Cognitive Restructuring for Posttraumatic Stress Disorder

ERIC Educational Resources Information Center

Bryant, Richard A.; Moulds, Michelle L.; Guthrie, Rachel M.; Dang, Suzanne T.; Mastrodomenico, Julie; Nixon, Reginald D. V.; Felmingham, Kim L.; Hopwood, Sally; Creamer, Mark

2008-01-01

Previous studies have reported that adding cognitive restructuring (CR) to exposure therapy does not enhance treatment gains in posttraumatic stress disorder (PTSD). This study investigated the extent to which CR would augment treatment response when provided with exposure therapy. The authors randomly allocated 118 civilian trauma survivors with…

Behavioral Family Intervention for Children with Developmental Disabilities and Behavioral Problems

ERIC Educational Resources Information Center

Roberts, Clare; Mazzucchelli, Trevor; Studman, Lisa; Sanders, Matthew R.

2006-01-01

The outcomes of a randomized clinical trial of a new behavioral family intervention, Stepping Stones Triple P, for preschoolers with developmental and behavior problems are presented. Forty-eight children with developmental disabilities participated, 27 randomly allocated to an intervention group and 20 to a wait-list control group. Parents…

Menstruation and Education in Nepal. NBER Working Paper No. 14853

ERIC Educational Resources Information Center

Oster, Emily; Thornton, Rebecca

2009-01-01

This paper presents the results from a randomized evaluation that distributed menstrual cups (menstrual sanitary products) to adolescent girls in rural Nepal. Girls in the study were randomly allocated a menstrual cup for use during their monthly period and were followed for fifteen months to measure the effects of having modern sanitary products…

Individual mineral supplement intake by ewes swath grazing or confinement fed pea-barley forage

USDA-ARS?s Scientific Manuscript database

Sixty mature ewes (non-pregnant, non-lactating) were used in a completely randomized design to determine if feeding method of pea-barley forage (swath grazing or hay in confinement) had an effect on individual ewe mineral consumption. Thirty ewes were randomly allocated to 3 confinement pens and 30 ...

Promoting Protective Factors for Young Adolescents: ABCD Parenting Young Adolescents Program Randomized Controlled Trial

ERIC Educational Resources Information Center

Burke, Kylie; Brennan, Leah; Cann, Warren

2012-01-01

This study examined the efficacy of a program for parents of young adolescents combining behavioral family intervention with acceptance-based strategies. 180 parents were randomly allocated to a 6-session group ABCD Parenting Young Adolescent Program or wait-list condition. Completer analysis indicated parents in the intervention reported…

Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

ERIC Educational Resources Information Center

Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

2013-01-01

The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

College Students' Reasons for Concealing Suicidal Ideation

ERIC Educational Resources Information Center

Burton Denmark, Adryon; Hess, Elaine; Becker, Martin Swanbrow

2012-01-01

Self-reported reasons for concealing suicidal ideation were explored using data from a national survey of undergraduate and graduate students: 558 students indicated that they seriously considered attempting suicide during the previous year and did not tell anyone about their suicidal thoughts. Content analysis of students' qualitative responses…

Behavioral Indicators of Legal and Illegal Gun Carrying

DTIC Science & Technology

2015-05-01

wide variety of handguns , in a wide variety of sizes and shapes, made of a wide variety of materials , and this variation is likely to have a subtle...Under Clothing/Belt ..................................................................................................... 23 Concealment of Handgun ...in Center of Chest ..................................................................................... 24 Concealment of Handgun in Groin Area with

As-built design specification for proportion estimate software subsystem

NASA Technical Reports Server (NTRS)

Obrien, S. (Principal Investigator)

1980-01-01

The Proportion Estimate Processor evaluates four estimation techniques in order to get an improved estimate of the proportion of a scene that is planted in a selected crop. The four techniques to be evaluated were provided by the techniques development section and are: (1) random sampling; (2) proportional allocation, relative count estimate; (3) proportional allocation, Bayesian estimate; and (4) sequential Bayesian allocation. The user is given two options for computation of the estimated mean square error. These are referred to as the cluster calculation option and the segment calculation option. The software for the Proportion Estimate Processor is operational on the IBM 3031 computer.

An interfering Go/No-go task does not affect accuracy in a Concealed Information Test.

PubMed

Ambach, Wolfgang; Stark, Rudolf; Peper, Martin; Vaitl, Dieter

2008-04-01

Following the idea that response inhibition processes play a central role in concealing information, the present study investigated the influence of a Go/No-go task as an interfering mental activity, performed parallel to the Concealed Information Test (CIT), on the detectability of concealed information. 40 undergraduate students participated in a mock-crime experiment and simultaneously performed a CIT and a Go/No-go task. Electrodermal activity (EDA), respiration line length (RLL), heart rate (HR) and finger pulse waveform length (FPWL) were registered. Reaction times were recorded as behavioral measures in the Go/No-go task as well as in the CIT. As a within-subject control condition, the CIT was also applied without an additional task. The parallel task did not influence the mean differences of the physiological measures of the mock-crime-related probe and the irrelevant items. This finding might possibly be due to the fact that the applied parallel task induced a tonic rather than a phasic mental activity, which did not influence differential responding to CIT items. No physiological evidence for an interaction between the parallel task and sub-processes of deception (e.g. inhibition) was found. Subjects' performance in the Go/No-go parallel task did not contribute to the detection of concealed information. Generalizability needs further investigations of different variations of the parallel task.

A non-imaging polarized terahertz passive system for detecting and identifying concealed explosives

NASA Astrophysics Data System (ADS)

Karam, Mostafa A.; Meyer, Doug

2011-06-01

Existing terahertz THz systems for detecting concealed explosives are not capable of identifying explosive type which leads to higher false alarm rates. Moreover, some of those systems are imaging systems that invade personal privacy, and require more processing and computational resources. Other systems have no polarization preference which makes them incapable of capturing the geometric features of an explosive. In this study a non-imaging polarized THz passive system for detecting and identifying concealed explosives overcoming the forgoing shortcomings is developed. The system employs a polarized passive THz sensor in acquiring emitted data from a scene that may have concealed explosives. The acquired data are decomposed into their natural resonance frequencies, and the number of those frequencies is used as criteria in detecting the explosive presence. If the presence of an explosive is confirmed, a set of physically based retrieval algorithms is used in extracting the explosive dielectric constant/refractive index value from natural resonance frequencies and amplitudes of associated signals. Comparing the refractive index value against a database of refractive indexes of known explosives identifies the explosive type. As an application, a system having a dual polarized radiometer operating within the frequency band of 0.62- 0.82 THz is presented and used in detecting and identifying person borne C-4 explosive concealed under a cotton garment. The system showed higher efficiencies in detecting and identifying the explosive.

Anxiety and Related Disorders and Concealment in Sexual Minority Young Adults.

PubMed

Cohen, Jeffrey M; Blasey, Christine; Barr Taylor, C; Weiss, Brandon J; Newman, Michelle G

2016-01-01

Sexual minorities face greater exposure to discrimination and rejection than heterosexuals. Given these threats, sexual minorities may engage in sexual orientation concealment in order to avoid danger. This social stigma and minority stress places sexual minorities at risk for anxiety and related disorders. Given that three fourths of anxiety disorder onset occurs before the age of 24, the current study investigated the symptoms of generalized anxiety disorder, social phobia, panic disorder, posttraumatic stress disorder, and depression in sexual minority young adults relative to their heterosexual peers. Secondarily, the study investigated sexual orientation concealment as a predictor of anxiety and related disorders. A sample of 157 sexual minority and 157 heterosexual young adults matched on age and gender completed self-report measures of the aforementioned disorders, and indicated their level of sexual orientation concealment. Results revealed that sexual minority young adults reported greater symptoms relative to heterosexuals across all outcome measures. There were no interactions between sexual minority status and gender, however, women had higher symptoms across all disorders. Sexual minority young women appeared to be at the most risk for clinical levels of anxiety and related disorders. In addition, concealment of sexual orientation significantly predicted symptoms of social phobia. Implications are offered for the cognitive and behavioral treatment of anxiety and related disorders in this population. Copyright © 2015. Published by Elsevier Ltd.

Long-term outcomes in women with polycystic ovary syndrome initially randomized to receive laparoscopic electrocautery of the ovaries or ovulation induction with gonadotrophins.

PubMed

Nahuis, M J; Kose, N; Bayram, N; van Dessel, H J H M; Braat, D D M; Hamilton, C J C M; Hompes, P G A; Bossuyt, P M; Mol, B W J; van der Veen, F; van Wely, M

2011-07-01

Long-term effects of laparoscopic electrocautery of the ovaries are unknown. To study the long-term effects of laparoscopic electrocautery of the ovaries and gonadotrophins, we followed women with clomiphene-resistant polycystic ovary syndrome (PCOS) randomly allocated to one of these treatments until 8-12 years after their initial treatment. Between February 1998 and October 2001 168 women with clomiphene citrate-resistant PCOS were included in a randomized controlled trial comparing an electrocautery strategy to a strategy starting with rFSH. In 2009 these women were contacted about their reproductive outcome and menstrual cycle regularity. Analysis was by intention-to-treat. We compared time to conception resulting in live birth, subsequent pregnancies, ectopic and multiple pregnancies, menopause, as well as minimal and maximal menstrual cycle length. After 8-12 years, the cumulative proportion of women with a first child was 86% in women who had been allocated to electrocautery versus 81% in women who had been allocated to immediate rFSH [relative ratio (RR): 1.1; 95% confidence interval (CI): 0.92-1.2]. Treatment with electrocautery resulted in a significantly lower need for stimulated cycles to reach a live birth; 53% after electrocautery versus 76% after rFSH (RR: 0.69; 95% CI: 0.55-0.88).The cumulative proportion of women with a second child was 61% after electrocautery versus 46% after immediate rFSH (RR: 1.4; 95% CI: 1.00-1.9). Overall, there were 7 twins out of 134 deliveries (5%) after electrocautery versus 10 twins out of 124 deliveries (8%) in the rFSH group (RR: 0.65; 95% CI: 0.25-1.6). Fifty-four per cent of the women allocated to electrocautery had a regular menstrual cycle 8-12 years after randomization versus 36% in those allocated to rFSH (RR: 1.5; 95% CI: 0.87-2.6). In women with clomiphene-resistant PCOS, laparoscopic electrocautery of the ovaries is as effective as ovulation induction with FSH treatment in terms of live births, but reduces the need for ovulation induction or ART in a significantly higher proportion of women and increases the chance for a second child. Clinicians may use these data when informing clomiphene-resistant anovulatory women about treatment options.

Detection and classification of concealed weapons using a magnetometer-based portal

NASA Astrophysics Data System (ADS)

Kotter, Dale K.; Roybal, Lyle G.; Polk, Robert E.

2002-08-01

A concealed weapons detection technology was developed through the support of the National Institute of Justice (NIJ) to provide a non intrusive means for rapid detection, location, and archiving of data (including visual) of potential suspects and weapon threats. This technology, developed by the Idaho National Engineering and Environmental Laboratory (INEEL), has been applied in a portal style weapons detection system using passive magnetic sensors as its basis. This paper will report on enhancements to the weapon detection system to enable weapon classification and to discriminate threats from non-threats. Advanced signal processing algorithms were used to analyze the magnetic spectrum generated when a person passes through a portal. These algorithms analyzed multiple variables including variance in the magnetic signature from random weapon placement and/or orientation. They perform pattern recognition and calculate the probability that the collected magnetic signature correlates to a known database of weapon versus non-weapon responses. Neural networks were used to further discriminate weapon type and identify controlled electronic items such as cell phones and pagers. False alarms were further reduced by analyzing the magnetic detector response by using a Joint Time Frequency Analysis digital signal processing technique. The frequency components and power spectrum for a given sensor response were derived. This unique fingerprint provided additional information to aid in signal analysis. This technology has the potential to produce major improvements in weapon detection and classification.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

27 CFR 447.62 - False statements or concealment of facts.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true False statements or concealment of facts. 447.62 Section 447.62 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION IMPORTATION OF ARMS, AMMUNITION AND...

27 CFR 447.62 - False statements or concealment of facts.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false False statements or concealment of facts. 447.62 Section 447.62 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION IMPORTATION OF ARMS, AMMUNITION AND...

27 CFR 447.62 - False statements or concealment of facts.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true False statements or concealment of facts. 447.62 Section 447.62 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION IMPORTATION OF ARMS, AMMUNITION AND...

27 CFR 447.62 - False statements or concealment of facts.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false False statements or concealment of facts. 447.62 Section 447.62 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION IMPORTATION OF ARMS, AMMUNITION AND...

27 CFR 447.62 - False statements or concealment of facts.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false False statements or concealment of facts. 447.62 Section 447.62 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION IMPORTATION OF ARMS, AMMUNITION AND...

Information Management Strategies in Early Adolescence: Developmental Change in Use and Transactional Associations with Psychological Adjustment

ERIC Educational Resources Information Center

Laird, Robert D.; Marrero, Matthew D.; Melching, Jessica A.; Kuhn, Emily S.

2013-01-01

Adolescents use various strategies to manage their parents' access to information. This study tested developmental change in strategy use, longitudinal associations between disclosing and concealing strategies, and longitudinal associations linking disclosing and concealing strategies with antisocial behavior and depressive symptoms. Self-report…

Automated Human Screening for Detecting Concealed Knowledge

ERIC Educational Resources Information Center

Twyman, Nathan W.

2012-01-01

Screening individuals for concealed knowledge has traditionally been the purview of professional interrogators investigating a crime. But the ability to detect when a person is hiding important information would be of high value to many other fields and functions. This dissertation proposes design principles for and reports on an implementation…

Concealed Questions. In Search of Answers

ERIC Educational Resources Information Center

Frana, Ilaria

2010-01-01

This dissertation examines the semantic interpretation of various types of DPs in so-called concealed-question (CQ) constructions, as "Bill's phone number" in the sentence "John knows Bill's phone number". The peculiar characteristic of DP-CQs is that they are interpreted as having the meaning of an embedded question. So, for instance, the…

Hard x-ray focusing optics for concealed object detection

NASA Astrophysics Data System (ADS)

Jannson, Tomasz; Gertsenshteyn, Michael

2006-05-01

In this paper, we discuss hard x-ray optics, in general, and lobster-eye focusing optics, in particular, for concealed object detection, at longer distances. The longer distance (~50m) scenario is important for Improvised Explosives Detection (IED), "seeing through walls," "seeing objects under ground," and related applications.

Ground roost resource selection for Merriam's wild turkeys

Treesearch

Chad P. Lehman; Daniel J. Thompson; Mark A. Rumble

2010-01-01

Concealment cover is important for ground-roosting wild turkey (Meleagris gallopavo) poults immediately following hatch during the vulnerable, preflight stage. We compared concealment cover resources selected at ground roosts to those of nest sites and available resources for Merriam's turkeys (Meleagris gallopavo merriami) in the Black Hills of South Dakota, USA...

Anabolic steroids for the treatment of weight loss in HIV-infected individuals.

PubMed

Johns, K; Beddall, M J; Corrin, R C

2005-10-19

Individuals with HIV infection often lose weight during the course of their disease. Furthermore, low serum concentrations of testosterone are common in individuals with HIV infection, particularly those with weight loss. Treatment of weight loss with anabolic steroids in HIV-infected individuals may be beneficial. Our objectives were to assess the efficacy and safety of anabolic steroids for the treatment of weight loss in adults with HIV infection. We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, AIDSLINE, AIDSearch, EMBASE, CINAHL, Current Contents, and the National Library of Medicine Gateway Abstracts for controlled trials up to April 2005. We also searched the bibliographies of the identified studies and review the articles. In addition, pharmaceutical manufacturers of anabolic steroids were contacted. Randomized controlled trials that compared the use of an anabolic steroid to placebo to treat weight loss in adults with HIV were included. Randomized controlled trials that compared the use of anabolic steroids to placebo for the treatment of weight loss in adults with HIV were selected. Change from baseline in lean body mass or in body weight was reported as on outcome measure. Two reviewers independently assessed the trials for quality of randomization, blinding, withdrawals, and adequacy of allocation concealment. For continuous data, weighted mean differences (WMD) were calculated. For dichotomous outcomes, risk differences, were calculated. Because of uncertainty as to whether consistent true effects exist in such different populations and treatments, the authors decided a priori to use random effects models for all outcomes. Thirteen trials met the inclusion criteria. Two hundred ninety-four individuals randomized to anabolic steroid therapy and 238 individuals randomized to placebo were included in the analysis of efficacy for change from baseline in lean body mass. Three hundred forty-three individuals randomized to anabolic steroid and 286 randomized to placebo were included in the analysis of efficacy for change from baseline in body weight. The mean methodologic quality of the included studies was 4.1, of a maximum 5 points. Although significant heterogeneity was present for both outcomes, the average change in lean body mass was 1.3 kg (95% CI: 0.6, 2.0), while the average change in total body weight was 1.1 kg (95% CI: 0.3, 2.0). A total of eight deaths occurred during the treatment period; four in the anabolic steroid treatment groups and four in the placebo-treatment groups (risk difference 0.00, 95% CI -0.03, 0.03). The risk difference for withdrawals or discontinuations of study medication due to adverse events was 0.00 (95% CI: -0.02, 0.03). Although the results of the trials were heterogeneous, on average, the administration of anabolic steroids appeared to result in a small increase in both lean body mass and body weight as compared with placebo. While these results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, due to limitations, treatment recommendations cannot be made. Further information is required regarding the long-term benefit and adverse effects of anabolic steroid use, the specific populations for which anabolic steroid therapy may be most beneficial, and the optimal regime. In addition, the correlation of improvement in lean body mass with more clinically relevant endpoints, such as physical functioning and survival, needs to be determined.

Identifying the location of a concealed object through unintentional eye movements

PubMed Central

Neuman, Yair; Assaf, Dan; Israeli, Navot

2015-01-01

In some investigative and interrogative contexts, the investigator is seeking to identify the location of an object (e.g., implanted bomb) which is known to a given subject (e.g., a terrorist). In this paper, we present a non-intrusive methodology for uncovering the loci of a concealed object by analyzing the subject's eye movements. Using a combination of eye tracking, psychological manipulation and a search algorithm, we have performed two experiments. In the first experiment, we have gained 58% hit rate in identifying the location of the concealed object and in the second experiment 56% hit rate. The pros and cons of the methodology for forensic investigation are discussed. PMID:25904879

The relationship between perfectionism and engagement in preventive health behaviours: the mediating role of self-concealment.

PubMed

Williams, Charlotte J; Cropley, Mark

2014-10-01

If perfectionists avoid engaging in preventive health behaviours, they may be putting their long-term health and well-being at risk. Correlational analyses based on a sample of 370 university students identified maladaptive perfectionism to be associated with decreased levels of engagement in preventive health behaviours, life satisfaction and well-being and increased levels of self-concealment and psychological distress. Adaptive perfectionism was associated with higher levels of engagement in preventive health behaviours. Self-concealment was identified as a partial mediator in the relationship between maladaptive perfectionism and both engagement in preventive health behaviours and psychological distress. Implications of the findings are discussed. © The Author(s) 2013.

Being and feeling unique: statistical deviance and psychological marginality.

PubMed

Frable, D E

1993-03-01

Two studies tested the hypothesis that people with culturally stigmatized and concealable conditions (e.g., gays, epileptics, juvenile delinquents, and incest victims) would be more likely to feel unique than people with culturally valued or conspicuous conditions (e.g., the physically attractive, the intellectually gifted, the obese, and the facially scarred). In Study 1, culturally stigmatized individuals with concealable conditions were least likely to perceive consensus between their personal preferences and those of others. In Study 2, they were most likely to describe themselves as unique and to make these self-relevant decisions quickly. Marginality is a psychological reality, not just a statistical one, for those with stigmatized and concealable "master status" conditions.